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A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD)

Information source: LEO Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Atopic Dermatitis

Intervention: Pimecrolimus cream (Drug); Betamethasone dipropionate cream (Drug); Clobetasol propionate cream (Drug); Glaxal Base cream vehicle (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: LEO Pharma

Official(s) and/or principal investigator(s):
Emma Guttmann, MD, Principal Investigator, Affiliation: Icahn School of Medicine

Summary

An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults with Mild to Moderate Atopic Dermatitis.

Clinical Details

Official title: An Explorative Clinical Trial to Evaluate an Intra Patient Comparison Design of Topical Agents in Adults With Mild to Moderate Atopic Dermatitis

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

Primary outcome: Total Sign Score (TSS) change

Detailed description: Multi-center, prospective, randomized, vehicle-controlled, investigator-blinded, stable lesion design.

Eligibility

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

Criteria:

Inclusion Criteria:

- Subject with mild to moderate AD

- Four comparable TAs

- TSS of at least 5 on all TAs

- Difference in TSS not greater than 2 between the TAs

- Sign score erythema ≥ 2 between the TAs

- TAs should be at least 2 cm apart

Exclusion Criteria:

- Investigator's opinion

- Fitzpatrick skin type >5

- Topical (i. e. on the TAs) treatment with prohibited medications

- Systemic treatment with prohibited medications

- Phototherapy within prohibited timeframe

- Use of emollients within prohibited timeframe

Locations and Contacts

Beit Harofim, Netanya 42701, Israel

Innovaderm Research Inc., Montreal, Quebec H2K 4L5, Canada

Additional Information

Starting date: February 2015
Last updated: July 24, 2015

Page last updated: August 23, 2015

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