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CompletedNCT01591785Updated Dec 3, 2020Results posted

Treatment of Staphylococcus Aureus Colonization in Hand Eczema

An interventional study of Retapamulin 1% ointment and Placebo in Hand Eczema and Foot Eczema, sponsored by Gary Goldenberg. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-03.

Sponsored by Gary Goldenberg · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

Atopic dermatitis is a chronic disease characterized by itching and eczematous lesions. In adults, eczema commonly localizes to the hands or feet. Several studies have implicated bacterial contamination, especially with Staphylococcus aureus (S. aureus), to be a factor in atopic dermatitis, as infection with this bacteria correlates with disease severity. No trial to date has investigated how to treat S. aureus infection in adults with hand or hand/foot dermatitis. Using retapamulin ointment in the nose and on the hands or hands/feet, the investigators expect to have a significant clearance rate of s. aureus infection. The investigators believe that treating the bacterial infection along with treating the condition with a topical corticosteroid will significantly decrease the severity of hand/foot dermatitis in our study population.

Read the detailed description

Primary Study Objectives:

  1. To evaluate the efficacy of retapamulin 1% ointment with clobetasol propionate 0.05% foam versus vehicle ointment with clobetasol propionate 0.05% foam as a treatment regimen for hand or hand/foot atopic dermatitis.
  2. To evaluate the incidence of intranasal and hand/foot S aureus carriage rates in subjects with hand/foot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the hand/foot dermatitis.
  3. To evaluate the incidence of mupirocin-resistance and methicillin-resistance in S aureus isolates in subjects with hand/foot atopic dermatitis via cultures of an anterior nare and the most severely graded target lesion of the hand/foot dermatitis.

Primary and secondary endpoints will be analyzed by appropriate statistical models by a qualified statistician. Any results of this pilot study will be treated as exploratory and hypothesis generating.

02

Conditions studied

  • Hand Eczema
  • Foot Eczema

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Keywords

  • Hand
  • Foot
  • Eczema
  • Atopic Dermatitis
03

In context

Eczema

1,084 studies on the registry are indexed under Eczema; 137 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 861 interventional studies indexed under Eczema.

Browse Eczema studies →

Lead sponsor

This is the only study on the registry with Gary Goldenberg 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

  • Male or female subjects at least 18 years of age with a clear diagnosis of moderate-to-severe hand or hand/foot dermatitis.
  • Subjects must be in general good health as confirmed by a medical history.
  • Subjects must be capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed.
  • At the Baseline Visit, Subjects must have a Physician's Global Assessment (PGA) of at least 3 (moderate severity).
  • Subject must be willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up period periods and comply with all study requirements.
  • If a subject is a female of childbearing potential she must have a negative urine pregnancy test prior to study treatment initiation and must agree to use an approved method of birth control during the study period (barrier, oral, injection, intrauterine). NOTE: Post-menopausal (amenorrhea for at least one year) or surgically sterile (tubal ligation and/or hysterectomy) females are categorized as non-childbearing potential.

Exclusion criteria

Exclusion Criteria:

  • Non-English speaking subjects
  • Females who are pregnant, breast feeding, or attempting to conceive.
  • Subjects with a history of known or suspected intolerance to any of the excipients of retapamulin 1% ointment or clobetasol propionate 0.05% foam.
  • Subjects who have used any topical corticosteroids, topical antibiotics, topical immunosuppressants, other topical therapies (tar, calcineurin inhibitors), or phototherapy (PUVA, UVB) within eight weeks of the Baseline Visit.
  • Subjects who have used any systemic corticosteroids, systemic antibiotics, or systemic immunosuppressants therapies within eight weeks of the Baseline Visit.
  • Subjects with any overt signs of skin atrophy, telangiectasias, and/or striae in the target area(s).
  • Subjects with any active skin malignancy.
  • Subjects requiring the use of medications known to alter the course of atopic dermatitis during the study period.
  • Subjects who are currently participating in or, within the previous 28 days, have participated in another study for the treatment for atopic dermatitis.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Retapamulin 1% ointment

    Retapamulin 1% ointment for 5 days AND clobetasol propionate foam for 14 days

    Drug: Retapamulin 1% ointment

  • Placebo comparator
    Placebo ointment

    Placebo ointment for 5 days AND clobetasol propionate foam for 14 days

    Drug: Placebo

Interventions

  • DrugRetapamulin 1% ointment

    Retapamulin 1% ointment for 5 days AND clobetasol propionate foam for 14 days

    Also known as: Altabax and Olux Foam

  • DrugPlacebo

    Placebo ointment for 5 days AND clobetasol propionate foam for 14 days

    Also known as: Petroleum jelly

06

What researchers measure

Primary outcomes

  1. Number of Participants With PGA of 0 or 1

    Physician's Global Assessment PGA 0 = Clear (no inflammatory signs of atopic dermatitis) 1 = Almost clear (just perceptible erythema and papulation/infiltration)

    Time frame: Day 15

  2. Number of Participants With PGA of 0 or 1

    Physician's Global Assessment PGA 0 = Clear (no inflammatory signs of atopic dermatitis) 1 = Almost clear (just perceptible erythema and papulation/infiltration)

    Time frame: Day 28

Secondary outcomes

  1. Staph Aureus Culture Results

    The percentage of subjects who had both negative S. aureus skin and nares cultures with a PGA of clear/almost clear at day 15 compared to baseline

    Time frame: Day 15

  2. Staph Aureus Culture Results

    The percentage of subjects who had both negative S. aureus skin and nares cultures with a PGA of clear/almost clear at day 28 compared to baseline

    Time frame: Day 28

07

Results

Posted Dec 3, 2020
Limitations and caveats
The study size was small. Study was only four weeks in duration, which is a snap-shot of a chronic life-long disease. Study was a single-center study which might not be a representative of the general population.

Participant flow

The study was conducted from January 2012 to August 2012, all subjects were enrolled at one site.

Participant flow — Overall Study
MilestoneRetapamulin 1% OintmentPlacebo Ointment
Started3030
Completed2628
Not completed42
Withdrew: Worsening condition12
Withdrew: Protocol violation20
Withdrew: Lost to follow-up10

Outcome measures

PrimaryNumber of Participants With PGA of 0 or 1

Physician's Global Assessment PGA 0 = Clear (no inflammatory signs of atopic dermatitis) 1 = Almost clear (just perceptible erythema and papulation/infiltration)

Time frame:
Day 15
Reported as:
Number · participants
Number of Participants With PGA of 0 or 1
participantsRetapamulin 1% OintmentPlacebo Ointment
Number of Participants With PGA of 0 or 12214
Statistical analysis
  • Retapamulin 1% Ointment vs Placebo Ointment · Chi-squared · p = 0.035
PrimaryNumber of Participants With PGA of 0 or 1

Physician's Global Assessment PGA 0 = Clear (no inflammatory signs of atopic dermatitis) 1 = Almost clear (just perceptible erythema and papulation/infiltration)

Time frame:
Day 28
Reported as:
Number · participants
Number of Participants With PGA of 0 or 1
participantsRetapamulin 1% OintmentPlacebo Ointment
Number of Participants With PGA of 0 or 11511
Statistical analysis
  • Retapamulin 1% Ointment vs Placebo Ointment · Chi-squared · p = 0.28
SecondaryStaph Aureus Culture Results

The percentage of subjects who had both negative S. aureus skin and nares cultures with a PGA of clear/almost clear at day 15 compared to baseline

Time frame:
Day 15
Reported as:
Number · percentage of participants
Staph Aureus Culture Results
percentage of participantsRetapamulin 1% OintmentPlacebo Ointment
Staph Aureus Culture Results6130
Statistical analysis
  • Retapamulin 1% Ointment vs Placebo Ointment · Chi-squared · p = 0.0495
SecondaryStaph Aureus Culture Results

The percentage of subjects who had both negative S. aureus skin and nares cultures with a PGA of clear/almost clear at day 28 compared to baseline

Time frame:
Day 28
Reported as:
Number · percentage of participants
Staph Aureus Culture Results
percentage of participantsRetapamulin 1% OintmentPlacebo Ointment
Staph Aureus Culture Results2813
Statistical analysis
  • Retapamulin 1% Ointment vs Placebo Ointment · Chi-squared · p = 0.27

Adverse events

Collected over 8 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Retapamulin 1% Ointment0/30 (0%)0/30 (0%)5/30 (16.7%)
Placebo Ointment0/30 (0%)0/30 (0%)3/30 (10%)
Most frequent other events
Most frequent other events
EventRetapamulin 1% OintmentPlacebo Ointment
Upper respiratory infectionRespiratory, thoracic and mediastinal disorders2/301/30
Urinary Tract InfectionRenal and urinary disorders1/300/30
Eczema flareSkin and subcutaneous tissue disorders1/301/30
DrynessSkin and subcutaneous tissue disorders0/301/30
PruritusSkin and subcutaneous tissue disorders1/300/30

Baseline characteristics

Age, Continuous
Age, Continuous(years)Retapamulin 1% OintmentPlacebo OintmentTotal
Mean41.5 (22 to 77)44.4 (23 to 70)43 (22 to 77)
Sex: Female, Male
Sex: Female, Male(Participants)Retapamulin 1% OintmentPlacebo OintmentTotal
Female172037
Male131023
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Retapamulin 1% OintmentPlacebo OintmentTotal
Hispanic or Latino61016
Not Hispanic or Latino242044
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Retapamulin 1% OintmentPlacebo OintmentTotal
American Indian or Alaska Native000
Asian213
Native Hawaiian or Other Pacific Islander000
Black or African American11617
White172340
More than one race000
Unknown or Not Reported000
Physician Global Assessment (PGA)
Physician Global Assessment (PGA)(units on a scale)Retapamulin 1% OintmentPlacebo OintmentTotal
Mean3.5 (3 to 5)3.7 (3 to 5)3.6 (3 to 5)
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Study locations

1 site
  • Mount Sinai School of Medicine
    New York, New York 10029, United States
09

References and documents

Publications

  • Meding B, Lantto R, Lindahl G, Wrangsjo K, Bengtsson B. Occupational skin disease in Sweden--a 12-year follow-up. Contact Dermatitis. 2005 Dec;53(6):308-13. doi: 10.1111/j.0105-1873.2005.00731.x. PubMed 16364116 ↗
  • Williams RE, Gibson AG, Aitchison TC, Lever R, Mackie RM. Assessment of a contact-plate sampling technique and subsequent quantitative bacterial studies in atopic dermatitis. Br J Dermatol. 1990 Oct;123(4):493-501. doi: 10.1111/j.1365-2133.1990.tb01455.x. PubMed 2095181 ↗
  • Hanifin JM, Rogge JL. Staphylococcal infections in patients with atopic dermatitis. Arch Dermatol. 1977 Oct;113(10):1383-6. PubMed 911165 ↗
  • Leyden JJ, Marples RR, Kligman AM. Staphylococcus aureus in the lesions of atopic dermatitis. Br J Dermatol. 1974 May;90(5):525-30. doi: 10.1111/j.1365-2133.1974.tb06447.x. No abstract available. PubMed 4601016 ↗
  • Jensen JM, Folster-Holst R, Baranowsky A, Schunck M, Winoto-Morbach S, Neumann C, Schutze S, Proksch E. Impaired sphingomyelinase activity and epidermal differentiation in atopic dermatitis. J Invest Dermatol. 2004 Jun;122(6):1423-31. doi: 10.1111/j.0022-202X.2004.22621.x. PubMed 15175033 ↗
  • Arikawa J, Ishibashi M, Kawashima M, Takagi Y, Ichikawa Y, Imokawa G. Decreased levels of sphingosine, a natural antimicrobial agent, may be associated with vulnerability of the stratum corneum from patients with atopic dermatitis to colonization by Staphylococcus aureus. J Invest Dermatol. 2002 Aug;119(2):433-9. doi: 10.1046/j.1523-1747.2002.01846.x. PubMed 12190867 ↗
  • Komatsu N, Saijoh K, Kuk C, Liu AC, Khan S, Shirasaki F, Takehara K, Diamandis EP. Human tissue kallikrein expression in the stratum corneum and serum of atopic dermatitis patients. Exp Dermatol. 2007 Jun;16(6):513-9. doi: 10.1111/j.1600-0625.2007.00562.x. PubMed 17518992 ↗
  • Sandilands A, Terron-Kwiatkowski A, Hull PR, O'Regan GM, Clayton TH, Watson RM, Carrick T, Evans AT, Liao H, Zhao Y, Campbell LE, Schmuth M, Gruber R, Janecke AR, Elias PM, van Steensel MA, Nagtzaam I, van Geel M, Steijlen PM, Munro CS, Bradley DG, Palmer CN, Smith FJ, McLean WH, Irvine AD. Comprehensive analysis of the gene encoding filaggrin uncovers prevalent and rare mutations in ichthyosis vulgaris and atopic eczema. Nat Genet. 2007 May;39(5):650-4. doi: 10.1038/ng2020. Epub 2007 Apr 8. PubMed 17417636 ↗
  • Haslund P, Bangsgaard N, Jarlov JO, Skov L, Skov R, Agner T. Staphylococcus aureus and hand eczema severity. Br J Dermatol. 2009 Oct;161(4):772-7. doi: 10.1111/j.1365-2133.2009.09353.x. Epub 2009 Jul 3. PubMed 19575755 ↗
  • Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of Staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 2009 May;123(5):e808-14. doi: 10.1542/peds.2008-2217. PubMed 19403473 ↗
  • Naderer OJ, A.M., Roberts K, et al. , Nasal Decolonization of persistent Staphylococcus aureus carriers with twice daily application of retapamulin ointment, 1%, for 3 or 5 days. , in Presented at the joint 48th annual interscience conference on antimicrobial agents adn chemotherapy at the 46th Annual Meeting of Infectious Diseases Society of America. 2008: Washington DC.
  • Haddican M, Linkner RV, Singer G, Jim SC, Gagliotti M, Goldenberg G. Retapamulin 1% Ointment and Clobetasol Propionate 0.05% Foam is More Efficacious than Vehicle Ointment and Clobetasol 0.05% Propionate Foam in the Treatment of Hand/Foot Dermatitis: A Single Center, Randomized, Double-blind Study. J Clin Aesthet Dermatol. 2014 Jul;7(7):32-6. PubMed 25053981 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01591785
Lead sponsor
Gary Goldenberg
Responsible party
Gary Goldenberg (Principal Investigator, Icahn School of Medicine at Mount Sinai) — Sponsor-investigator
First posted
May 4, 2012
Start date
Jan 2012
Primary completion
Aug 2012
Completion
Aug 2012
Results posted
Dec 3, 2020
Last update
Dec 3, 2020

Study contacts

Gary Goldenberg, MD
principal investigator · Icahn School of Medicine at Mount Sinai

Oversight

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

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