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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

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.

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

Eligibility

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

Criteria:

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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