Hydrogel Patch for the Treatment of Eczema

NCT00924508 | Terminated Results

• 1 other identifier: Hydrogel for Eczema
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this clinical study is to determine whether occlusion of triamcinolone 0.1% cream (TAC) with hydrogel patch improves its efficacy in treating eczema. A secondary objective is to determine whether eczema improves under occlusion with hydrogel patch alone, without TAC.

Conditions

Eczema

Keywords

eczema; at least 3 patches of eczema

Outcome Measures

Primary Outcomes (1)

• Change in Disease Severity: Percent Change in Mean EASI Score

  Percent change in mean EASI score week 0 to week 6: Each lesion was scored using a 12-point modified Eczema Area and Severity Index (EASI) at baseline and 2 weeks after the 4-week treatment period (week6). An experienced evaluator assessed each lesion on the severity of 4 domains, with higher scores indicating more severity: 1) intensity of redness (erythema), 2) thickness (induration, papulation, oedema), 3) scratching (excoriation) and 4) lichenification (lined skin) as as none (0), mild (1), moderate (2) and severe (3). Pictorial and descriptive instructions guided the evaluator in scoring the lesions based on visual appearance.

  Baseline, 6 weeks

Secondary Outcomes (1)

• Number of Adverse Events Associated With Treatment

  6 weeks

Study Arms (1)

Patch + cream, patch alone, cream alone

EXPERIMENTAL

This is a single arm study. Each subject will have 3 target lesions; one treated with TAC 0.1% cream and hydrogel patch (occlusion), the second treated with cream alone, and the third treated with occlusion alone.

Device: hydrogel patch; Drug: Triamcinolone (TAC) 0.1% cream

Interventions

hydrogel patch DEVICE

occlusion of eczema with a hydrogel patch composed of an adhesive, thin, flexible, hydrogel layer on an impermeable urethane surface.

Also known as: Occlusion, Patch, Hydrogel

Patch + cream, patch alone, cream alone

Triamcinolone (TAC) 0.1% cream DRUG

Triamcinolone Acetonide (triamcinolone acetonide cream) is a topical corticosteroid used as anti-inflammatory and antipruritic agent. Each gram of TAC Cream USP, 0.1% contains 1 mg Triamcinolone Acetonide (triamcinolone acetonide cream) in a cream base consisting of cetyl alcohol, glyceryl monostearate, cetyl esters wax, isopropyl palmitate, polysorbate-60, polysorbate-80, propylene glycol and purified water.

Also known as: Triamcinolone Acetonide cream, TAC cream [United States Pharmacopeia, (USP), 0.1%]

Patch + cream, patch alone, cream alone

Eligibility Criteria

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

You may qualify if:

• Subject has signed the informed consent form and Health Insurance Portability and Accountability Act (HIPAA) authorization form;
• Male or female subject at least 12 years of age; subjects under 18 years of age will need parental or official guardian consent.
• A diagnosis of eczema with at least three lesions no larger than 7 by 7 cm on either the trunk, arms, or legs that would serve as target lesions. The lesions must be wide enough apart so that there is no overlap of hydrogel patches. All three lesions must have at least 5 out of 12 points on the modified EASI scale. Each of the three lesions must have no greater than 1 point difference from each other on the modified EASI score. (If the subject can identify specific eczema lesions that are more pruritic, recalcitrant and/or tend to initiate the itch-scratch cycle, then those lesions will be preferentially selected as the target lesions.)
• Any additional diagnoses must, in the investigator's opinion, not preclude the subject from safely participating in this study or interfere with the evaluation of the subject's eczema;
• Subject is able to completely discontinue the use of any medication or therapy (other than study medications) for relief of eczema in the target areas to be treated;
• Subject is able to completely discontinue the use of any systemic medication or therapy (e.g. oral medications, phototherapy, herbal remedies, or acupuncture) for relief of eczema;
• Subject must be reliable and mentally competent to complete study measurements;
• Subject is able to understand and agrees to comply with study requirements, attend study visits, and comply with the restrictions during the study.

You may not qualify if:

• Subjects with exclusively hand, face, foot, and/or groin dermatitis
• Known hypersensitivity to any component of the test medications;
• Pigmentation, extensive scarring, or pigmented lesions in affected areas that would interfere with evaluation of efficacy parameters;
• Clinically infected eczema at baseline.
• Any evidence of atrophy in the areas selected for treatment with topical corticosteroid;
• Subjects requiring any other medication (topical or systemic) that may affect the course of the disease during the study period (e.g. oral corticosteroids, immunosuppressants, antibiotics, sedating antihistamines). Inhaled steroids will be permitted.
• Topical therapies (other than non-prescription emollients) on potential target lesions within one week of starting study treatment;
• Systemic therapy, phototherapy, or a systemic investigational therapy for eczema within 30 days prior to study entry;
• Subject is considered unreliable as to medication compliance or adherence to scheduled appointments as determined by the investigators.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Teikoku Pharma USA, Inc.: collaborator

Study Sites (1)

UCSF Psoriasis Skin and Treatment Center

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Eczema

Interventions

Dental Occlusion; Transdermal Patch; Bandages, Hydrocolloid; Triamcinolone

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Equipment and Supplies; Bandages; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

Due to loss of funding, enrollment was terminated prior to intended accrual of 30 participants.

Results Point of Contact

• Title: John Koo, MD
• Organization: UCSF

john.koo@ucsfmedctr.org

415-476-6281

Study Officials

• John Koo, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 19, 2009
• Study Start: July 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: July 1, 2012
• Last Updated: January 31, 2014
• Results First Posted: November 25, 2013

Record last verified: 2013-12

Locations

US (1)