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TerminatedNCT01125930Updated Jul 16, 2014Results posted

Atralin Gel for the Treatment of Rosacea

A Phase 3 interventional study of vehicle gel and Atralin gel in Rosacea, sponsored by Lisa E. Maier. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-16.

Sponsored by Lisa E. Maier · Phase 3, Interventional, and Treatment

Why this study was terminated
Due to slow recruitment and sponsor request study ended early
Phase
Phase 3
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Erythematotelangiectatic rosacea is a type of rosacea that causes a red face often with frequent flushing, topical sensitivity and prominent blood vessels. We think that long term damage to skin from the sun (photodamage) may play a role in causing this type of rosacea. Tretinoin is a topical medication that is known to improve photodamage. We want to find out if Atralin (tretinoin 0.05%) Gel used for up to 46 weeks will improve erythematotelangiectatic rosacea (ETR).

02

Conditions studied

  • Rosacea

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Keywords

  • rosacea
  • tretinoin
  • atralin
03

In context

Rosacea

225 studies on the registry are indexed under Rosacea; 19 are open to participants now.

This study's enrollment of 68 is above the median of 61 across 195 interventional studies indexed under Rosacea.

Browse Rosacea studies →

Lead sponsor

This is the only study on the registry with Lisa E. Maier as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects 18 years of age and older of any race.
  2. Clinical diagnosis of mild to moderate erythematotelangiectatic facial rosacea based on physician evaluation.
  3. Willing and able to understand and sign informed consent.
  4. Able to complete study and comply with study procedures.

Exclusion criteria

Exclusion Criteria:

  1. Severe self reported facial sensitivity
  2. History of allergy to fish
  3. Severe sun sensitivity
  4. Severe erythematotelangiectatic rosacea requiring systemic treatment
  5. Papulopustular, Ocular-only, Phymatous rosacea, Steroid rosacea, pyoderma faciale
  6. Unwilling to undergo facial biopsies
  7. Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids
  8. Use of topical rosacea treatments in the past 2 weeks.
  9. Use of systemic antibiotics in the past 4 weeks.
  10. Use of systemic retinoids within the past 6 months.
  11. Use of topical retinoids within the past 3 months
  12. Use of laser or light based rosacea treatments within the past 2 months.
  13. Cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face) within the past two months
  14. Use of topical anti-aging medications including alpha hydroxy acids, salicylic acid, beta-hydroxy acid, vitamin A, vitamin E, ascorbic acid
  15. Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments.
  16. Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
  17. If female, Subjects who are either of non-child bearing potential (defined as postmenopausal -absence of menstrual bleeding for 1 year - or as having undergone bilateral tubal ligation, hysterectomy or bilateral ovariectomy) or, if of childbearing potential, Subjects who have had a negative urine pregnancy test at the beginning of the study, and have agreed to practice appropriate birth-control to prevent pregnancy during the study.(The type and dose of birth control must have been stable for at least 2 months prior to study entry and not be expected to change during the study).
  18. Subjects who are lactating.
  19. Use of any investigational therapy within the past 4 weeks.
  20. Known hypersensitivity or previous allergic reaction to retinoids
  21. Carcinoid, Pheochromocytoma or other systemic flushing causes
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
68 participants (actual)

Study arms

  • Placebo comparator
    Vehicle gel

    Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.

    Drug: vehicle gel

  • Active comparator
    Atralin gel

    Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.

    Drug: Atralin gel

Interventions

  • Drugvehicle gel

    Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.

  • DrugAtralin gel

    Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.

06

What researchers measure

Primary outcomes

  1. Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)

    Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin

    Time frame: 24 weeks

  2. Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia

    Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin

    Time frame: 24 weeks

  3. Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema

    Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin

    Time frame: 24 weeks

  4. Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin

    Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin

    Time frame: 24 weeks

  5. Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing

    Flushing is defined as a temporary redness of the face, neck and chest. Subjects were asked to choose the best answer that applied to them in response to the questions "Do you have flushing?".

    Time frame: 24 weeks

  6. Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning

    Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the facial burning feature of their rosacea.

    Time frame: 24 weeks

  7. Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging

    Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the Facial Stinging feature of their rosacea.

    Time frame: 24 weeks

  8. Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product

    Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance.

    Time frame: 24 weeks

Secondary outcomes

  1. Quality of Life

    The Dermatology Life Quality Index (DLQI) questionnaire was given at each visit. It involves 10 questions that relate to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The total DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

    Time frame: 2, 6, 12, 18, 24 weeks

  2. Photodamage

    Photodamage was measured at baseline and Week 24 visits using the nine point Hamilton-Griffiths Photoaging Score categories. The categories were developed using photographs of subject representing grades of photodamge from none (0) to severe (8). A direct comparison is made between the subject and the photographic standards. If an exact match cannot be made, the interstandard scores (1, 3, 5, 7) are used.

    Time frame: 24 weeks

  3. Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea

    Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea

    Time frame: 2, 6, 12, 18 and 24 weeks

  4. Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea

    Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea

    Time frame: 2, 6, 12, 18 and 24 weeks

  5. Signs of Other Rosacea Subtypes: Papulopustular

    Signs of other rosacea subtypes includes papulopustular, inflammatory papule count

    Time frame: 2, 6, 12, 18, 24 weeks

  6. Molecular Markers of Inflammation

    These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of inflammation include Tachykinin 1 (TAC1), CXC Motif Receptor 4 (CXCR4), CXC Motif Ligand 12 (CXCL12), and Tumor Necrosis Factor Alpha (TNFa).

    Time frame: 24 weeks

  7. Molecular Evidence of Photodamage

    These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of photodamage include Collagen 1 (COL-1), Collagen 3 (COL-3), Matrix Metalloproteinase 1 (MMP1), Matrix Metalloproteinase 3 (MMP3), and Matrix Metalloproteinase 9 (MMP9).

    Time frame: 24 weeks

  8. Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)

    Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.

    Time frame: 2, 6, 12, 18 weeks

  9. Severity of Erythematotelangiectatic Signs: Telangiectasia

    Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.

    Time frame: 2, 6, 12, 18 weeks

  10. Severity of Erythematotelangiectatic Signs: Facial Edema

    Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.

    Time frame: 2, 6, 12, 18 weeks

  11. Severity of Erythematotelangiectatic Signs: Dryness/Irritation

    Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.

    Time frame: 2, 6, 12, 18 weeks

  12. Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing

    Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance

    Time frame: 2, 6, 12, 18 weeks

  13. Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning

    Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance

    Time frame: 2, 6, 12, 18 weeks

  14. Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging

    Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance

    Time frame: 2, 6, 12, 18 weeks

  15. Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment

    Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance

    Time frame: 2, 6, 12, 18 weeks

  16. Skin Irritation Assessed by Facial Stinging Upon Product Application

    Time frame: 2, 6, 12, 18 weeks

  17. Skin Irritation Assessed by Facial Itching Upon Product Application

    Time frame: 2, 6, 12, 18 weeks

  18. Skin Irritation Assessed by Facial Burning Upon Product Application

    Time frame: 2, 6, 12, 18 weeks

07

Results

Posted Jul 16, 2014
Limitations and caveats
Early termination of study due to slow recruitment and sponsor request resulted in smaller number of subjects analyzed.

Participant flow

Participant flow — Overall Study
MilestoneVehicle GelAtralin Gel
Started2246
Completed2136
Not completed110
Withdrew: Adverse event01
Withdrew: Withdrawal by subject16
Withdrew: Protocol violation01
Withdrew: Lost to follow-up02

Outcome measures

PrimarySeverity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)

Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin

Time frame:
24 weeks
Reported as:
Number · participants
Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)
participantsVehicle GelAtralin Gel
None00
Mild Erythema1222
Moderate Erythema913
Marked Erythema01
Deep Erythema00
Statistical analysis
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 0.93Wilcoxon rank sum test with exact p-values.
PrimarySeverity of Erythematotelangiectatic Rosacea Signs: Telangiectasia

Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin

Time frame:
24 weeks
Reported as:
Number · participants
Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia
participantsVehicle GelAtralin Gel
None10
Mild1022
Moderate1013
Severe01
Statistical analysis
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 0.79Wilcoxon rank sum test with exact p-values.
SecondaryQuality of Life

The Dermatology Life Quality Index (DLQI) questionnaire was given at each visit. It involves 10 questions that relate to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The total DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.

Time frame:
2, 6, 12, 18, 24 weeks
Reported as:
Mean · units on a scale
Quality of Life
units on a scaleVehicle Gel at Week 2Atralin Gel at Week 2Vehicle Gel at Week 6Atralin Gel at Week 6Vehicle Gel at Week 12Atralin Gel at Week 12Vehicle Gel at Week 18Atralin Gel at Week 18Vehicle Gel at Week 24Atralin Gel at Week 24
Quality of Life2.62 ± 3.012.28 ± 2.312.19 ± 2.362.44 ± 2.211.95 ± 2.252.03 ± 1.921.52 ± 1.632.14 ± 2.261.43 ± 1.602.14 ± 2.43
Statistical analysis
  • Vehicle Gel at Week 2 vs Atralin Gel at Week 2 · Wilcoxon (Mann-Whitney) · p = 0.94Wilcoxon rank sum test with exact p-values to address non-normality of data.
  • Vehicle Gel at Week 6 vs Atralin Gel at Week 6 · Wilcoxon (Mann-Whitney) · p = 0.57Wilcoxon rank sum test with exact p-values to address non-normality of data.
  • Vehicle Gel at Week 12 vs Atralin Gel at Week 12 · Wilcoxon (Mann-Whitney) · p = 0.66Wilcoxon rank sum test with exact p-values to address non-normality of data.
  • Vehicle Gel at Week 18 vs Atralin Gel at Week 18 · Wilcoxon (Mann-Whitney) · p = 0.38Wilcoxon rank sum test with exact p-values to address non-normality of data.
  • Vehicle Gel at Week 24 vs Atralin Gel at Week 24 · Wilcoxon (Mann-Whitney) · p = 0.24Wilcoxon rank sum test with exact p-values to address non-normality of data.
SecondaryPhotodamage

Photodamage was measured at baseline and Week 24 visits using the nine point Hamilton-Griffiths Photoaging Score categories. The categories were developed using photographs of subject representing grades of photodamge from none (0) to severe (8). A direct comparison is made between the subject and the photographic standards. If an exact match cannot be made, the interstandard scores (1, 3, 5, 7) are used.

Time frame:
24 weeks
Reported as:
Number · participants
Photodamage
participantsVehicle GelAtralin Gel
Score of 0, No Photo Damage00
Score of 1, Mild Photo Damage, < score of 231
Score of 2, Mild Photo Damage511
Score of 3, Mild Photo Damage, > score of 2412
Score of 4, Moderate Photo Damage59
Score of 5, Moderate Photo Damage, > score of 422
Score of 6, Moderate/Severe Photo Damage21
Score of 7, Severe Photo Damage, < score of 800
Score of 8, Severe Photo Damage00
Statistical analysis
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 0.87Wilcoxon rank sum test with exact p-values.
SecondarySigns of Other Rosacea Subtypes: Ocular Manifestations of Rosacea

Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea

Time frame:
2, 6, 12, 18 and 24 weeks
Reported as:
Number · participants
Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea
participantsVehicle Gel at Week 2Atralin Gel at Week 2Vehicle Gel at Week 6Atralin Gel at Week 6Vehicle Gel at Week 12Atralin Gel at Week 12Vehicle Gel at Week 18Atralin Gel at Week 18Vehicle Gel at Week 24Atralin Gel at Week 24
None18321931183219321934
Mild3424342412
Moderate0001000010
Severe0000000000
Statistical analysis
  • Vehicle Gel at Week 2 vs Atralin Gel at Week 2 · Wilcoxon (Mann-Whitney) · p = 1.00Wilcoxon rank sum test with exact p-values
  • Vehicle Gel at Week 6 vs Atralin Gel at Week 6 · Wilcoxon (Mann-Whitney) · p = 0.62Wilcoxon rank sum test with exact p-values
  • Vehicle Gel at Week 12 vs Atralin Gel at Week 12 · Wilcoxon (Mann-Whitney) · p = 1.00Wilcoxon rank-sum test with exact p-values
  • Vehicle Gel at Week 18 vs Atralin Gel at Week 18 · Wilcoxon (Mann-Whitney) · p = 1.00Wilcoxon rank sum test with exact p-values
  • Vehicle Gel at Week 24 vs Atralin Gel at Week 24 · Wilcoxon (Mann-Whitney) · p = 0.45Wilcoxon rank sum test with exact p-values.
SecondarySigns of Other Rosacea Subtypes: Phymatous Changes of Rosacea

Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea

Time frame:
2, 6, 12, 18 and 24 weeks
Reported as:
Number · participants
Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea
participantsVehicle Gel at Week 2Atralin Gel at Week 2Vehicle Gel at Week 6Atralin Gel at Week 6Vehicle Gel at Week 12Atralin Gel at Week 12Vehicle Gel at Week 18Atralin Gel at Week 18Vehicle Gel at Week 24Atralin Gel at Week 24
None21342134213421342135
Mild0202020201
Moderate0000000000
Statistical analysis
  • Vehicle Gel at Week 2 vs Atralin Gel at Week 2 · Wilcoxon (Mann-Whitney) · p = 0.53Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 6 vs Atralin Gel at Week 6 · Wilcoxon (Mann-Whitney) · p = 0.53Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 12 vs Atralin Gel at Week 12 · Wilcoxon (Mann-Whitney) · p = 0.53Wilcoxon rank sum test with exact p-values
  • Vehicle Gel at Week 18 vs Atralin Gel at Week 18 · Wilcoxon (Mann-Whitney) · p = 0.53Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 24 vs Atralin Gel at Week 24 · Wilcoxon (Mann-Whitney) · p = 1.00Wilcoxon rank sum test with exact p-values.
SecondarySigns of Other Rosacea Subtypes: Papulopustular

Signs of other rosacea subtypes includes papulopustular, inflammatory papule count

Time frame:
2, 6, 12, 18, 24 weeks
Reported as:
Mean · inflammatory papule
Signs of Other Rosacea Subtypes: Papulopustular
inflammatory papuleVehicle Gel at Week 2Atralin Gel at Week 2Vehicle Gel at Week 6Atralin Gel at Week 6Vehicle Gel at Week 12Atralin Gel at Week 12Vehicle Gel at Week 18Atralin Gel at Week 18Vehicle Gel at Week 24Atralin Gel at Week 24
Signs of Other Rosacea Subtypes: Papulopustular0.19 ± 0.510.25 ± 0.730.14 ± 0.480.28 ± 0.660.43 ± 0.870.50 ± 1.590.48 ± 0.870.64 ± 1.590.38 ± 0.671.03 ± 2.69
Statistical analysis
  • Vehicle Gel at Week 2 vs Atralin Gel at Week 2 · Wilcoxon (Mann-Whitney) · p = 1.00Wilcoxon rank sum test with exact p-values to address non-normality of data.
  • Vehicle Gel at Week 6 vs Atralin Gel at Week 6 · Wilcoxon (Mann-Whitney) · p = 0.41Wilcoxon rank sum test with exact p-values to address non-normality of data.
  • Vehicle Gel at Week 12 vs Atralin Gel at Week 12 · Wilcoxon (Mann-Whitney) · p = 0.66Wilcoxon rank sum test with exact p-values to address non-normality of data.
  • Vehicle Gel at Week 18 vs Atralin Gel at Week 18 · Wilcoxon (Mann-Whitney) · p = 0.92Wilcoxon rank sum test with exact p-values to address non-normality of data.
  • Vehicle Gel at Week 24 vs Atralin Gel at Week 24 · Wilcoxon (Mann-Whitney) · p = 0.80Wilcoxon rank sum test with exact p-values to address non-normality of data.
SecondaryMolecular Markers of Inflammation

These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of inflammation include Tachykinin 1 (TAC1), CXC Motif Receptor 4 (CXCR4), CXC Motif Ligand 12 (CXCL12), and Tumor Necrosis Factor Alpha (TNFa).

Time frame:
24 weeks
Reported as:
Mean · fold change
Molecular Markers of Inflammation
fold changeVehicle GelAtralin Gel
TAC1 Fold Change Score2.91 ± 1.940.87 ± 0.90
CXCR4 Fold Change Score1.39 ± 1.181.88 ± 1.81
CXCL12 Fold Change Score1.10 ± 0.801.20 ± 0.59
TNFa Fold Change Score1.24 ± 0.841.17 ± 0.97
Statistical analysis
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 0.003Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 0.35Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 0.68Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 0.76Wilcoxon rank sum test with exact p-values.
SecondaryMolecular Evidence of Photodamage

These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of photodamage include Collagen 1 (COL-1), Collagen 3 (COL-3), Matrix Metalloproteinase 1 (MMP1), Matrix Metalloproteinase 3 (MMP3), and Matrix Metalloproteinase 9 (MMP9).

Time frame:
24 weeks
Reported as:
Mean · fold change
Molecular Evidence of Photodamage
fold changeVehicle GelAtralin Gel
COL-1 Fold Change Score1.50 ± 1.091.17 ± 0.65
COL-3 Fold Change Score1.39 ± 0.771.04 ± 0.63
MMP1 Fold Change Score1.44 ± 1.280.83 ± 0.60
MMP3 Fold Change Score2.87 ± 3.580.69 ± 0.64
MMP9 Fold Change Score2.53 ± 4.161.67 ± 1.60
Statistical analysis
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 1.00Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 0.25Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 0.41Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 0.02Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 0.61Wilcoxon rank sum test with exact p-values.
SecondarySeverity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)

Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.

Time frame:
2, 6, 12, 18 weeks
Reported as:
Number · participants
Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)
participantsVehicle Gel at Week 2Atralin Gel at Week 2Vehicle Gel at Week 6Atralin Gel at Week 6Vehicle Gel at Week 12Atralin Gel at Week 12Vehicle Gel at Week 18Atralin Gel at Week 18
None01111010
Mild Erythema1118111612201123
Moderate Erythema1017918814911
Marked Erythema00010202
Deep Erythema00000000
Statistical analysis
  • Vehicle Gel at Week 2 vs Atralin Gel at Week 2 · Wilcoxon (Mann-Whitney) · p = 1.00Wilcoxon rank sum test with exact p-values
  • Vehicle Gel at Week 6 vs Atralin Gel at Week 6 · Wilcoxon (Mann-Whitney) · p = 0.44Wilcoxon rank sum test with exact p-values
  • Vehicle Gel at Week 12 vs Atralin Gel at Week 12 · Wilcoxon (Mann-Whitney) · p = 0.41Wilcoxon rank sum test with exact p-values
  • Vehicle Gel at Week 18 vs Atralin Gel at Week 18 · Wilcoxon (Mann-Whitney) · p = 0.94Wilcoxon rank sum test with exact p-values
PrimarySeverity of Erythematotelangiectatic Rosacea Signs: Facial Edema

Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin

Time frame:
24 weeks
Reported as:
Number · participants
Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema
participantsVehicle GelAtralin Gel
None2131
Mild05
Moderate00
Severe00
Statistical analysis
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 0.15Wilcoxon rank sum test with exact p-values.
PrimarySeverity of Erythematotelangiectatic Rosacea Signs: Dry Skin

Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin

Time frame:
24 weeks
Reported as:
Number · participants
Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin
participantsVehicle GelAtralin Gel
None1316
Slight Flaking712
Moderate Flaking/Scaling18
Marked Scaling/Fissuring00
Severe Scaling/Fissuring00
Statistical analysis
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 0.13Wilcoxon rank sum test with exact p-values.
PrimarySeverity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing

Flushing is defined as a temporary redness of the face, neck and chest. Subjects were asked to choose the best answer that applied to them in response to the questions "Do you have flushing?".

Time frame:
24 weeks
Reported as:
Number · participants
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing
participantsVehicle GelAtralin Gel
Yes1933
No23
Statistical analysis
  • Vehicle Gel vs Atralin Gel · Fisher Exact · p = 1.00
PrimarySeverity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning

Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the facial burning feature of their rosacea.

Time frame:
24 weeks
Reported as:
Number · participants
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning
participantsVehicle GelAtralin Gel
None1528
Mild67
Moderate01
Severe00
Statistical analysis
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 0.75Wilcoxon rank sum test with exact p-values.
PrimarySeverity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging

Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the Facial Stinging feature of their rosacea.

Time frame:
24 weeks
Reported as:
Number · participants
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging
participantsVehicle GelAtralin Gel
None1727
Mild48
Moderate01
Severe00
Statistical analysis
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 0.68Wilcoxon rank sum test with exact p-values.
PrimarySeverity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product

Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance.

Time frame:
24 weeks
Reported as:
Number · participants
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product
participantsVehicle GelAtralin Gel
Strongly like product28
Like product77
Neutral916
Dislike product35
Strongly dislike product00
Statistical analysis
  • Vehicle Gel vs Atralin Gel · Wilcoxon (Mann-Whitney) · p = 0.77Wilcoxon rank sum test with exact p-values.
SecondarySeverity of Erythematotelangiectatic Signs: Telangiectasia

Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.

Time frame:
2, 6, 12, 18 weeks
Reported as:
Number · participants
Severity of Erythematotelangiectatic Signs: Telangiectasia
participantsVehicle Gel at Week 2Atralin Gel at Week 2Vehicle Gel at Week 6Atralin Gel at Week 6Vehicle Gel at Week 12Atralin Gel at Week 12Vehicle Gel at Week 18Atralin Gel at Week 18
None00101010
Mild71791910201021
Moderate1418111610151014
Severe01010101
Statistical analysis
  • Vehicle Gel at Week 2 vs Atralin Gel at Week 2 · Wilcoxon (Mann-Whitney) · p = 0.41Wilcoxon rank sum test with exact p-values
  • Vehicle Gel at Week 6 vs Atralin Gel at Week 6 · Wilcoxon (Mann-Whitney) · p = 1.00Wilcoxon rank sum test with exact p-values
  • Vehicle Gel at Week 12 vs Atralin Gel at Week 12 · Wilcoxon (Mann-Whitney) · p = 0.96Wilcoxon rank sum test with exact p-values
  • Vehicle Gel at Week 18 vs Atralin Gel at Week 18 · Wilcoxon (Mann-Whitney) · p = 0.91Wilcoxon rank sum test with exact p-values
SecondarySeverity of Erythematotelangiectatic Signs: Facial Edema

Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.

Time frame:
2, 6, 12, 18 weeks
Reported as:
Number · participants
Severity of Erythematotelangiectatic Signs: Facial Edema
participantsVehicle Gel at Week 2Atralin Gel at Week 2Vehicle Gel at Week 6Atralin Gel at Week 6Vehicle Gel at Week 12Atralin Gel at Week 12Vehicle Gel at Week 18Atralin Gel at Week 18
None2133213321312132
Mild02030504
Moderate01000000
Severe00000000
Statistical analysis
  • Vehicle Gel at Week 2 vs Atralin Gel at Week 2 · Wilcoxon (Mann-Whitney) · p = 0.29Wilcoxon rank sum test with exact p-values
  • Vehicle Gel at Week 6 vs Atralin Gel at Week 6 · Wilcoxon (Mann-Whitney) · p = 0.29Wilcoxon rank sum test with exact p-values
  • Vehicle Gel at Week 12 vs Atralin Gel at Week 12 · Wilcoxon (Mann-Whitney) · p = 0.15Wilcoxon rank sum test with exact p-values
  • Vehicle Gel at Week 18 vs Atralin Gel at Week 18 · Wilcoxon (Mann-Whitney) · p = 0.29Wilcoxon rank sum test with exact p-values
SecondarySeverity of Erythematotelangiectatic Signs: Dryness/Irritation

Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.

Time frame:
2, 6, 12, 18 weeks
Reported as:
Number · participants
Severity of Erythematotelangiectatic Signs: Dryness/Irritation
participantsVehicle Gel at Week 2Atralin Gel at Week 2Vehicle Gel at Week 6Atralin Gel at Week 6Vehicle Gel at Week 12Atralin Gel at Week 12Vehicle Gel at Week 18Atralin Gel at Week 18
None813131312101314
Slight Flaking1217719818614
Moderate Flaking/Scaling15131728
Marked Scaling/Fissuring01010000
Severe Scaling/Fissuring00000100
Statistical analysis
  • Vehicle Gel at Week 2 vs Atralin Gel at Week 2 · Wilcoxon (Mann-Whitney) · p = 0.54Wilcoxon rank sum test with exact p-values
  • Vehicle Gel at Week 6 vs Atralin Gel at Week 6 · Wilcoxon (Mann-Whitney) · p = 0.06Wilcoxon rank sum test with exact p-values
  • Vehicle Gel at Week 12 vs Atralin Gel at Week 12 · Wilcoxon (Mann-Whitney) · p = 0.02Wilcoxon rank sum test with exact p-values
  • Vehicle Gel at Week 18 vs Atralin Gel at Week 18 · Wilcoxon (Mann-Whitney) · p = 0.09Wilcoxon rank sum test with exact p-values
SecondarySeverity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing

Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance

Time frame:
2, 6, 12, 18 weeks
Reported as:
Number · participants
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing
participantsVehicle Gel at Week 2Atralin Gel at Week 2Vehicle Gel at Week 6Atralin Gel at Week 6Vehicle Gel at Week 12Atralin Gel at Week 12Vehicle Gel at Week 18Atralin Gel at Week 18
Yes1734183218321834
No42343432
Statistical analysis
  • Vehicle Gel at Week 2 vs Atralin Gel at Week 2 · Fisher Exact · p = 0.18
  • Vehicle Gel at Week 6 vs Atralin Gel at Week 6 · Fisher Exact · p = 0.70
  • Vehicle Gel at Week 12 vs Atralin Gel at Week 12 · Fisher Exact · p = 0.70
  • Vehicle Gel at Week 18 vs Atralin Gel at Week 18 · Fisher Exact · p = 0.35
SecondarySeverity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning

Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance

Time frame:
2, 6, 12, 18 weeks
Reported as:
Number · participants
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning
participantsVehicle Gel at Week 2Atralin Gel at Week 2Vehicle Gel at Week 6Atralin Gel at Week 6Vehicle Gel at Week 12Atralin Gel at Week 12Vehicle Gel at Week 18Atralin Gel at Week 18
None1626172416231624
Mild3731058510
Moderate22110502
Severe01010000
Statistical analysis
  • Vehicle Gel at Week 2 vs Atralin Gel at Week 2 · Wilcoxon (Mann-Whitney) · p = 0.80Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 6 vs Atralin Gel at Week 6 · Wilcoxon (Mann-Whitney) · p = 0.31Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 12 vs Atralin Gel at Week 12 · Wilcoxon (Mann-Whitney) · p = 0.25Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 18 vs Atralin Gel at Week 18 · Wilcoxon (Mann-Whitney) · p = 0.46Wilcoxon rank sum test with exact p-values.
SecondarySeverity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging

Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance

Time frame:
2, 6, 12, 18 weeks
Reported as:
Number · participants
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging
participantsVehicle Gel at Week 2Atralin Gel at Week 2Vehicle Gel at Week 6Atralin Gel at Week 6Vehicle Gel at Week 12Atralin Gel at Week 12Vehicle Gel at Week 18Atralin Gel at Week 18
None1725192419261926
Mild4102102928
Moderate00020002
Severe01000100
Statistical analysis
  • Vehicle Gel at Week 2 vs Atralin Gel at Week 2 · Wilcoxon (Mann-Whitney) · p = 0.41Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 6 vs Atralin Gel at Week 6 · Wilcoxon (Mann-Whitney) · p = 0.05Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 12 vs Atralin Gel at Week 12 · Wilcoxon (Mann-Whitney) · p = 0.16Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 18 vs Atralin Gel at Week 18 · Wilcoxon (Mann-Whitney) · p = 0.14Wilcoxon rank sum test with exact p-values.
SecondarySeverity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment

Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance

Time frame:
2, 6, 12, 18 weeks
Reported as:
Number · participants
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment
participantsVehicle Gel at Week 2Atralin Gel at Week 2Vehicle Gel at Week 6Atralin Gel at Week 6Vehicle Gel at Week 12Atralin Gel at Week 12Vehicle Gel at Week 18Atralin Gel at Week 18
Strongly like product03232517
Like product384941159
Neutral1723132012181318
Dislike product02242222
Strongly dislike product00001000
Statistical analysis
  • Vehicle Gel at Week 2 vs Atralin Gel at Week 2 · Wilcoxon (Mann-Whitney) · p = 0.36Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 6 vs Atralin Gel at Week 6 · Wilcoxon (Mann-Whitney) · p = 0.88Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 12 vs Atralin Gel at Week 12 · Wilcoxon (Mann-Whitney) · p = 0.18Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 18 vs Atralin Gel at Week 18 · Wilcoxon (Mann-Whitney) · p = 0.17Wilcoxon rank sum test with exact p-values.
SecondarySkin Irritation Assessed by Facial Stinging Upon Product Application
Time frame:
2, 6, 12, 18 weeks
Reported as:
Number · participants
Skin Irritation Assessed by Facial Stinging Upon Product Application
participantsVehicle Gel at Week 2Atralin Gel at Week 2Vehicle Gel at Week 6Atralin Gel at Week 6Vehicle Gel at Week 12Atralin Gel at Week 12Vehicle Gel at Week 18Atralin Gel at Week 18
No stinging1724202020251925
A little stinging31211519211
A lot of stinging00010200
Statistical analysis
  • Vehicle Gel at Week 2 vs Atralin Gel at Week 2 · Wilcoxon (Mann-Whitney) · p = 0.21Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 6 vs Atralin Gel at Week 6 · Wilcoxon (Mann-Whitney) · p = <0.01Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 12 vs Atralin Gel at Week 12 · Wilcoxon (Mann-Whitney) · p = 0.04Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 18 vs Atralin Gel at Week 18 · Wilcoxon (Mann-Whitney) · p = 0.10Wilcoxon rank sum test with exact p-values.
SecondarySkin Irritation Assessed by Facial Itching Upon Product Application
Time frame:
2, 6, 12, 18 weeks
Reported as:
Number · participants
Skin Irritation Assessed by Facial Itching Upon Product Application
participantsVehicle Gel at Week 2Atralin Gel at Week 2Vehicle Gel at Week 6Atralin Gel at Week 6Vehicle Gel at Week 12Atralin Gel at Week 12Vehicle Gel at Week 18Atralin Gel at Week 18
No itching1831212721302131
A little itching25070504
A lot of itching00020101
Statistical analysis
  • Vehicle Gel at Week 2 vs Atralin Gel at Week 2 · Wilcoxon (Mann-Whitney) · p = 1.00Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 6 vs Atralin Gel at Week 6 · Wilcoxon (Mann-Whitney) · p = 0.02Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 12 vs Atralin Gel at Week 12 · Wilcoxon (Mann-Whitney) · p = 0.08Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 18 vs Atralin Gel at Week 18 · Wilcoxon (Mann-Whitney) · p = 0.15Wilcoxon rank sum test with exact p-values.
SecondarySkin Irritation Assessed by Facial Burning Upon Product Application
Time frame:
2, 6, 12, 18 weeks
Reported as:
Number · participants
Skin Irritation Assessed by Facial Burning Upon Product Application
participantsVehicle Gel at Week 2Atralin Gel at Week 2Vehicle Gel at Week 6Atralin Gel at Week 6Vehicle Gel at Week 12Atralin Gel at Week 12Vehicle Gel at Week 18Atralin Gel at Week 18
No burning1728192620241929
A little burning3721011026
A lot of burning01000201
Statistical analysis
  • Vehicle Gel at Week 2 vs Atralin Gel at Week 2 · Wilcoxon (Mann-Whitney) · p = 0.67Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 6 vs Atralin Gel at Week 6 · Wilcoxon (Mann-Whitney) · p = 0.18Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 12 vs Atralin Gel at Week 12 · Wilcoxon (Mann-Whitney) · p = 0.02Wilcoxon rank sum test with exact p-values.
  • Vehicle Gel at Week 18 vs Atralin Gel at Week 18 · Wilcoxon (Mann-Whitney) · p = 0.42Wilcoxon rank sum test with exact p-values.

Adverse events

Collected over Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Vehicle Gel—0/22 (0%)13/22 (59.1%)
Atralin Gel—1/46 (2.2%)25/46 (54.3%)
Most frequent serious events
Most frequent serious events
EventVehicle GelAtralin Gel
Right Hip OsteoarthritisSurgical and medical procedures0/221/46
Most frequent other events
Showing 10 of 31
Most frequent other events
EventVehicle GelAtralin Gel
Upper Respiratory Tract InfectionInfections and infestations6/229/46
Papular Inflammatory FlareSkin and subcutaneous tissue disorders0/227/46
Inflamed Lesion/CystsSkin and subcutaneous tissue disorders0/226/46
CongestionRespiratory, thoracic and mediastinal disorders1/225/46
Irritiated SkinSkin and subcutaneous tissue disorders0/225/46
Eczema/Atopic DermatitisSkin and subcutaneous tissue disorders2/225/46
Stomach FluInfections and infestations2/222/46
Actinic KeratosisSkin and subcutaneous tissue disorders2/223/46
Blurry VisionEye disorders1/220/46
NauseaGastrointestinal disorders1/220/46

Baseline characteristics

Age, Continuous
Age, Continuous(years)Vehicle GelAtralin GelTotal
Mean55.00 ± 11.2456.09 ± 11.5855.74 ± 11.39
Sex: Female, Male
Sex: Female, Male(Participants)Vehicle GelAtralin GelTotal
Female153954
Male7714
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Vehicle GelAtralin GelTotal
Caucasian, European descent224365
Caucasian, non-European descent022
Middle Eastern011
Region of Enrollment
Region of Enrollment(participants)Vehicle GelAtralin GelTotal
United States224668
08

Study locations

1 site
  • University of Michigan Department of Dermatology
    Ann Arbor, Michigan 48109, United States
09

References and documents

Publications

  • Pelle MT, Crawford GH, James WD. Rosacea: II. Therapy. J Am Acad Dermatol. 2004 Oct;51(4):499-512; quiz 513-4. doi: 10.1016/j.jaad.2004.03.033. PubMed 15389184 ↗
  • Ertl GA, Levine N, Kligman AM. A comparison of the efficacy of topical tretinoin and low-dose oral isotretinoin in rosacea. Arch Dermatol. 1994 Mar;130(3):319-24. PubMed 8129410 ↗
  • Vienne MP, Ochando N, Borrel MT, Gall Y, Lauze C, Dupuy P. Retinaldehyde alleviates rosacea. Dermatology. 1999;199 Suppl 1:53-6. doi: 10.1159/000051380. PubMed 10473962 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01125930
Lead sponsor
Lisa E. Maier
Collaborators
Bausch Health Americas, Inc.
Responsible party
Lisa E. Maier (Assistant Professor, University of Michigan) — Sponsor-investigator
First posted
May 19, 2010
Start date
May 2010
Primary completion
Jan 2013
Completion
Jan 2013
Results posted
Jul 16, 2014
Last update
Jul 16, 2014

Study contacts

Lisa E Maier, M.D.
principal investigator · University of Michigan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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