Treatment of Staphylococcus Aureus Colonization in Hand Eczema

Hand Eczema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01591785
• Other study ID #: GCO 11-0038
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: August 2012

Study information

• Verified date: December 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Eczema
• Foot Eczema
• Hand Eczema

Intervention

Drug:
• Retapamulin 1% ointment
Retapamulin 1% ointment for 5 days AND clobetasol propionate foam for 14 days
• Placebo
Placebo ointment for 5 days AND clobetasol propionate foam for 14 days

Locations

Country	Name	City	State
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Gary Goldenberg

Country where clinical trial is conducted

United States, 

References & Publications (12)

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. — View Citation

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 Si — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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.

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	Day 15
Secondary	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	Day 28