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OpenTrials
Completed

NCT Number: NCT02117752

Dermal Tolerability of Dapsone Gel in Healthy Volunteers

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fair Lawn, New Jersey, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dapsone gel

Drug

Patches containing dapsone gel will be applied to the skin.

dapsone gel vehicle

Drug

Patches containing dapsone gel vehicle will be applied to the skin.

sodium lauryl sulfate

Drug

Patches containing sodium lauryl sulfate (Positive Control) will be applied to the skin.

normal saline

Drug

Patches containing normal saline (Negative Control) will be applied to the skin.

Primary outcomes

  1. Mean Cumulative Irritation Index During Induction Phase

    Time frame: 21 Days

  2. Incidence of Sensitization Reactions During Challenge Phase

    Time frame: 6 Weeks

Sponsors and collaborators

Lead sponsor

Almirall, S.A.

Industry

Collaborators

  • Allergan

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 21, 2014
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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