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Trial record 16 of 49 for:    Sodium Lauryl Sulfate

Dermal Tolerability of Dapsone Gel in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02117752
Recruitment Status : Completed
First Posted : April 21, 2014
Last Update Posted : October 8, 2018
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Almirall, S.A.

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: dapsone gel Drug: dapsone gel vehicle Drug: sodium lauryl sulfate Drug: Normal saline Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 237 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : April 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Dapsone

Arm Intervention/treatment
Experimental: Dapsone Gel Subset 1
Dapsone gel, dapsone gel vehicle and controls applied to the skin by separate occlusive patches every 24 hours for 21 days followed by a 10 to 17 day rest period then one application each of dapsone gel and dapsone gel vehicle by patch for 48-hours.
Drug: dapsone gel
Patches containing dapsone gel will be applied to the skin.

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

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

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

Experimental: Dapsone Gel Subset 2
Dapsone gel, dapsone gel vehicle and negative control applied to the skin by separate occlusive patches every 48 to 72 hours for 21 days followed by a 10 to 17 day rest period then one application each of dapsone gel and dapsone gel vehicle by patch for 48-hours.
Drug: dapsone gel
Patches containing dapsone gel will be applied to the skin.

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

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




Primary Outcome Measures :
  1. Mean Cumulative Irritation Index During Induction Phase [ Time Frame: 21 Days ]
  2. Incidence of Sensitization Reactions During Challenge Phase [ Time Frame: 6 Weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02117752


Locations
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United States, New Jersey
Fair Lawn, New Jersey, United States
Sponsors and Collaborators
Almirall, S.A.
Allergan
Investigators
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Study Director: Medical Director Allergan

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Responsible Party: Almirall, S.A.
ClinicalTrials.gov Identifier: NCT02117752     History of Changes
Other Study ID Numbers: 225678-009
First Posted: April 21, 2014    Key Record Dates
Last Update Posted: October 8, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Dapsone
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Anti-Bacterial Agents