Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT01915758
Status:
COMPLETED
Last Update Posted:
2017-07-18
First Post:
2012-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
W0265-104: A Single-Center, Evaluator-Blinded, Randomized, Placebo-Controlled, Phase 1 Clinical Trial Evaluating the Photoallergic Potential of Topically Applied Clindamycin Phosphate 1.0% and Tretinoin 0.025% (CT Gel) in Healthy Volunteers
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
A Single-Center, Evaluator-Blinded, Randomized, Placebo-Controlled, Phase 1 Clinical Trial Evaluating the Photoallergic Potential of Topically Applied Clindamycin Phosphate 1.0% and Tretinoin 0.025% (CT Gel) in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This was a single-center, evaluator-blinded, randomized, placebo (vehicle) -controlled phase I study to evaluate the photoallergic potential of Clindamycin-Tretinoin Gel. The design consisted of the following periods: screening, induction, rest, challenge, and rechallenge (if indicated). Induction visit 1 was to occur within 5 days of screening visit 2. The study expected to enroll approximately 62 healthy adult volunteers. Subjects were to receive repeated 24-hour study patch applications; after patch removal, the sites were irradiated with ultraviolet B light (UVB) and visible light (VIS) during the induction period (consisting of 6 consecutive induction phases), and ultraviolet A light (UVA)/ UVB and VIS during the challenge and rechallenge periods. Each application site was observed approximately 1, 24, 48, and 72 hours later for signs of inflammation.
Detailed Description:
This was a single-center, evaluator-blinded, randomized, placebo (vehicle) -controlled phase I study to evaluate the photoallergic potential of Clindamycin-Tretinoin Gel. The design consisted of the following periods: screening, induction, rest, challenge, and rechallenge (if indicated). Induction visit 1 was to occur within 5 days of screening visit 2. The study expected to enroll approximately 62 healthy adult volunteers. Subjects were to receive repeated 24-hour study patch applications; after patch removal, the sites were irradiated with ultraviolet B light (UVB) and visible light (VIS) during the induction period (consisting of 6 consecutive induction phases), and ultraviolet A light (UVA)/ UVB and VIS during the challenge and rechallenge periods. Each application site was observed approximately 1, 24, 48, and 72 hours later for signs of inflammation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: