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Clinical Study to Evaluate Tolerability and Safety of ARK-E021 Foam and to Monitor Clinical Effect in Acne Vulgaris Patients

NCT01494285 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2013-12-03

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group, ambulatory safety and efficacy study of ARK-E021 topical foam of 5% and 10% in subjects with mild to moderate acne vulgaris.

Conditions

  • Acne Vulgaris

Interventions

DRUG

ARK-E021 5%

Topically applied once daily at bedtime

DRUG

ARK-E021 10%

Topically applied once daily at bedtime

DRUG

Placebo

Topically applied once daily at bedtime

Sponsors & Collaborators

  • Vyne Therapeutics Inc.

    collaborator INDUSTRY

  • M. Arkin 1999 Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs

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 NCT01494285 on ClinicalTrials.gov