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Dermal Tolerability of Dapsone Gel in Healthy Volunteers

Information source: Allergan
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: dapsone gel (Drug); dapsone gel vehicle (Drug); sodium lauryl sulfate (Drug); Normal saline (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan


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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Mean Cumulative Irritation Index During Induction Phase

Incidence of Sensitization Reactions During Challenge Phase


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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.

Locations and Contacts

Fair Lawn, New Jersey, United States
Additional Information

Starting date: April 2014
Last updated: September 12, 2014

Page last updated: August 20, 2015

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