Phase I Study of GN-037 Cream for Psoriasis
NCT05428202 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2023-06-13
Summary
In this Phase I study, three different doses (low, medium and high dose, on the basis of surface area applied) of GN-037 cream (12 volunteers in total) and placebo (6 volunteers in total) will be administered to healthy volunteers. In the active dose arm, 4 healthy volunteers will receive GN-037 cream and 2 healthy volunteers will receive placebo. Randomization in each dose arm will be 2:1.
Conditions
Interventions
- DRUG
-
GN037
GN-037 cream containing urea, salicylic acid, retinoic acid and clobetasol 17-propionate and matching placebo
- DRUG
-
Placebo cream containing base without active ingredients
Sponsors & Collaborators
-
Monitor CRO
collaborator INDUSTRY -
TC Erciyes University
lead OTHER
Principal Investigators
-
Oğuz Akbaş, MD · Monitor CRO
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-03-28
- Primary Completion
- 2022-04-28
- Completion
- 2022-09-30
Countries
- Turkey (Türkiye)
Study Locations
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