Treatment of Staphylococcus Aureus Colonization in Hand Eczema

NCT01591785 | Completed Results

• 1 other identifier: GCO 11-0038
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hand Eczema; Foot Eczema

Keywords

Hand; Foot; Eczema; Atopic Dermatitis

Outcome Measures

Primary Outcomes (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)

  Day 15

• 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)

  Day 28

Secondary Outcomes (2)

• Staph Aureus Culture Results

  Day 15

• Staph Aureus Culture Results

  Day 28

Study Arms (2)

Retapamulin 1% ointment

ACTIVE COMPARATOR

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

Drug: Retapamulin 1% ointment

Placebo ointment

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Retapamulin 1% ointment DRUG

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

Also known as: Altabax and Olux Foam

Retapamulin 1% ointment

Placebo DRUG

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

Also known as: Petroleum jelly

Placebo ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gary Goldenberg: lead

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Related Publications (12)

• 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.

  PMID: 16364116 BACKGROUND

• 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.

  PMID: 2095181 BACKGROUND

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

  PMID: 911165 BACKGROUND

• 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.

  PMID: 4601016 BACKGROUND

• 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.

  PMID: 15175033 BACKGROUND

• 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.

  PMID: 12190867 BACKGROUND

• 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.

  PMID: 17518992 BACKGROUND

• 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.

  PMID: 17417636 BACKGROUND

• 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.

  PMID: 19575755 BACKGROUND

• 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.

  PMID: 19403473 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25053981 RESULT

MeSH Terms

Conditions

Eczema; Dermatitis, Atopic

Interventions

retapamulin; Ointments; Petrolatum

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations; Hydrocarbons; Organic Chemicals

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.

Results Point of Contact

• Title: Gary Goldenberg, MD
• Organization: Icahn School of Medicine at Mount Sinai

garygoldenbergmd@gmail.com

212-241-6500

Study Officials

• Gary Goldenberg, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 4, 2012
• Study Start: January 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: December 3, 2020
• Results First Posted: December 3, 2020

Record last verified: 2020-12

Locations

US (1)