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CompletedNCT01047189Updated Sep 10, 2018Results posted

Adherence to Study Medication Compared to Generic Topical Clindamycin Plus Generic Topical Tretinoin in Subjects With Mild to Moderate Acne Vulgaris

A Phase 4 interventional study of clindamycin phosphate 1.2% and tretinoin 0.025% and clindamycin 1% gel in Acne Vulgaris, sponsored by Wake Forest University. Completed at 1 site in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2018-09-10.

Sponsored by Wake Forest University · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
26
Allocation
Randomized
Ages
12 Years and older
Sex
All
01

Study summary

The purpose of this research study is to evaluate the effectiveness of two different types of topical acne medication. This study will help to determine if one combined medication results in better acne improvement than two separate medications for acne.

02

Conditions studied

  • Acne Vulgaris

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Keywords

  • Mild to moderate acne vulgaris
03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's enrollment of 26 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Wake Forest University is the lead sponsor of 116 studies on the registry; 7 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 27 (87%) have results posted.

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

04

Who can participate

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

Inclusion criteria

  • Males or Females 12 years of age or older with a diagnosis of mild to moderate acne vulgaris.
  • Subjects must sign written informed consent and agree to come for all study visits.

Exclusion criteria

Exclusion Criteria:

  • Use of experimental drugs within 1 month prior to initiation of study therapy.
  • Pregnant and nursing females will not be allowed in the study, and females of childbearing potential will have a pregnancy test at baseline. Females of childbearing potential must agree to use approved birth control methods for the duration of the study.
  • Use of systemic retinoids within 2 months of enrollment, use of any topical retinoids, systemic antibiotics, nicotinamide, systemic steroids or any other medication that may confound the results of the study within 1 month prior to start of the study
  • Use of any other topical medications for acne, including cosmetics containing retinol, within 2 weeks prior to study entry.
  • Any skin condition or disease that may require concurrent therapy or may confound the evaluation;
  • History of hypersensitivity to any of the formulation components;
  • Facial skin cancer or facial actinic keratosis;
  • Use of any photosensitizing agents.
  • Use of isotretinoin within the last 6 months.
  • Chemical peels, microdermabrasion or laser resurfacing within 3 months of study entry.
  • Crohns disease, ulcerative colitis, or have developed colitis with past antibiotic use.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    1

    Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks

    Drug: clindamycin phosphate 1.2% and tretinoin 0.025%

  • Active comparator
    2

    Generic clindamycin 1% gel plus tretinoin 0.025% cream

    Drug: clindamycin 1% gel · Drug: tretinoin 0.025% cream

Interventions

  • Drugclindamycin phosphate 1.2% and tretinoin 0.025%

    applied once daily for 12 weeks

    Also known as: Ziana

  • Drugclindamycin 1% gel

    Topical clindamycin applied each morning for 12 weeks

  • Drugtretinoin 0.025% cream

    Tretinoin 0.025% cream each evening for 12 weeks

06

What researchers measure

Primary outcomes

  1. Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne

    Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap

    Time frame: 12 weeks

Secondary outcomes

  1. The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count

    Time frame: Baseline to 12 weeks

07

Results

Posted Oct 17, 2011

Participant flow

Participants were recruited from IRB approved advertising and the Wake Forest University Health Sciences Dermatology Clinic

Participant flow — Overall Study
MilestoneZiana GelClindamycin Plus Tretinoin Applied Separately
Started1313
Completed913
Not completed40

Outcome measures

PrimaryMeasured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne

Percentage of prescribed doses taken as measured by a Medication Event Monitoring System (MEMS) cap

Time frame:
12 weeks
Reported as:
Median · Percent of doses
Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne
Percent of dosesZiana GelClindamycin Plus Tretinoin Applied Separately
Measured Adherence to ZIANA Gel or Generic Topical Clindamycin 1% Gel Each Morning Plus Generic Topical Tretinoin 0.025% Cream Each Evening in Subjects With Mild to Moderate Acne88 (13 to 115)61 (8 to 95)
SecondaryThe Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count
Time frame:
Baseline to 12 weeks
Reported as:
Mean · percentage of lesions
The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count
percentage of lesionsZiana GelClindamycin Plus Tretinoin Applied Separately
The Change (Dynamic Assessment) From Baseline to Week 12 (or End of Treatment) in Total Acne Lesion Count-51 (-80 to -23)-32 (-66 to 2)
Statistical analysis
  • Ziana Gel vs Clindamycin Plus Tretinoin Applied Separately · Kruskal-Wallis · p = 0.05

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ziana Gel—0/13 (0%)1/13 (7.7%)
Clindamycin Plus Tretinoin Applied Separately—0/13 (0%)0/13 (0%)
Most frequent other events
Most frequent other events
EventZiana GelClindamycin Plus Tretinoin Applied Separately
Burning sensation on facial skinSkin and subcutaneous tissue disorders1/130/13

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Ziana GelClindamycin Plus Tretinoin Applied SeparatelyTotal
<=18 years729
Between 18 and 65 years61117
>=65 years000
Age, Continuous
Age, Continuous(years)Ziana GelClindamycin Plus Tretinoin Applied SeparatelyTotal
Mean20.1 (13 to 35)26.2 (15 to 40)23.1 (13 to 40)
Sex: Female, Male
Sex: Female, Male(Participants)Ziana GelClindamycin Plus Tretinoin Applied SeparatelyTotal
Female9615
Male4711
Region of Enrollment
Region of Enrollment(participants)Ziana GelClindamycin Plus Tretinoin Applied SeparatelyTotal
United States131326
08

Study locations

1 site
  • Wake Forest University Health Sciences, Dermatology
    Winston-Salem, North Carolina 27157, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 10, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01047189
Lead sponsor
Wake Forest University
Collaborators
Medicis Pharmaceutical Corporation
Responsible party
Sponsor
First posted
Jan 12, 2010
Start date
Mar 2009
Primary completion
Oct 2009
Completion
Oct 2009
Results posted
Oct 17, 2011
Last update
Sep 10, 2018

Study contacts

Steven R Feldman, MD, Ph.D
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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