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NCT02117752 Clinical Trial

Dermal Tolerability of Dapsone Gel in Healthy Volunteers

Healthy Volunteers Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02117752
Other study ID # 225678-009
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 2014
Est. completion date July 2014

Study information
Verified date October 2018
Source Almirall, S.A.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will determine the cumulative irritation potential and sensitization potential of dapsone gel and vehicle after repeat applications on the skin of healthy volunteers.

Recruitment information / eligibility
Status Completed
Enrollment 237
Est. completion date July 2014
Est. primary completion date July 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

-Healthy adults.

Exclusion Criteria:

- Skin diseases, excessive hair, tattoos, pigmentation, scars or moles that could interfere with patch application

- Sensitivity to adhesive bandages or tape.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• dapsone gel
Patches containing dapsone gel will be applied to the skin.
• dapsone gel vehicle
Patches containing dapsone gel vehicle will be applied to the skin.
• sodium lauryl sulfate
Patches containing sodium lauryl sulfate (Positive Control) will be applied to the skin.
• Normal saline
Patches containing normal saline (Negative Control) will be applied to the skin.

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Almirall, S.A. Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Cumulative Irritation Index During Induction Phase 21 Days
Primary Incidence of Sensitization Reactions During Challenge Phase 6 Weeks
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