Phase I Study of GN-037 Cream for Psoriasis

NCT05428202 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-06-13

No results posted yet for this study

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

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

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05428202 on ClinicalTrials.gov