- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02108483
Phototoxicity Test of Dapsone Gel in Healthy Volunteers
October 5, 2018 updated by: Almirall, S.A.
This study will evaluate the potential of dapsone gel and its vehicle to cause a phototoxic reaction following irradiation of the skin under controlled conditions.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
Fair Lawn, New Jersey, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: All participants
Dapsone gel and dapsone gel vehicle applied to the skin by separate occlusive patches on Day 1.
|
Patches containing dapsone gel will be applied to the skin.
Patches containing dapsone gel vehicle will be applied to the skin.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Phototoxicity Irritation Potential Using a Visual Scale
Time Frame: 4 Days
|
4 Days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
May 1, 2014
Study Completion (Actual)
May 1, 2014
Study Registration Dates
First Submitted
April 7, 2014
First Submitted That Met QC Criteria
April 8, 2014
First Posted (Estimate)
April 9, 2014
Study Record Updates
Last Update Posted (Actual)
October 9, 2018
Last Update Submitted That Met QC Criteria
October 5, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 225678-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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