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NCT02376049 Clinical Trial

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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02376049
Other study ID # EXP-1184
Secondary ID
Status Completed
Phase Phase 1
First received February 25, 2015
Last updated May 1, 2017
Start date February 2015
Est. completion date July 2015

Study information
Verified date May 2017
Source LEO Pharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Pimecrolimus cream

• Betamethasone dipropionate cream

• Clobetasol propionate cream

• Glaxal Base cream vehicle

Locations
Country Name City State
Canada Innovaderm Research Inc. Montreal Quebec
Israel Beit Harofim Netanya

Sponsors (1)
Lead Sponsor Collaborator
LEO Pharma

Countries where clinical trial is conducted

Canada,  Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Total Sign Score (TSS) change TSS change at end of treatment in relation to baseline 14 days
See also
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