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Treatment of Staphylococcus Aureus Colonization in Hand Eczema

Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hand Eczema; Foot Eczema

Intervention: Retapamulin 1% ointment (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Gary Goldenberg

Official(s) and/or principal investigator(s):
Gary Goldenberg, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai


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.

Clinical Details

Official title: An Investigator-Initiated Study: Treatment of Staphylococcus Aureus Colonization in Hand Eczema Decreases Severity of Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Physician Assessments

Physician Assessments

Physician Assessments

Secondary outcome:

Staph Aureus culture results

Staph Aureus culture results

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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:

- 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.

Locations and Contacts

Mount Sinai School of Medicine, New York, New York 10029, United States
Additional Information

Related publications:

Meding B, Lantto R, Lindahl G, Wrangsjö K, Bengtsson B. Occupational skin disease in Sweden--a 12-year follow-up. Contact Dermatitis. 2005 Dec;53(6):308-13.

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.

Hanifin JM, Rogge JL. Staphylococcal infections in patients with atopic dermatitis. Arch Dermatol. 1977 Oct;113(10):1383-6.

Leyden JJ, Marples RR, Kligman AM. Staphylococcus aureus in the lesions of atopic dermatitis. Br J Dermatol. 1974 May;90(5):525-30.

Jensen JM, Fölster-Holst R, Baranowsky A, Schunck M, Winoto-Morbach S, Neumann C, Schütze S, Proksch E. Impaired sphingomyelinase activity and epidermal differentiation in atopic dermatitis. J Invest Dermatol. 2004 Jun;122(6):1423-31.

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.

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.

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. Epub 2007 Apr 8.

Haslund P, Bangsgaard N, Jarløv 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.

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.

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.

Starting date: January 2012
Last updated: July 8, 2015

Page last updated: August 23, 2015

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