MedTrace Logo

Comparison of the Efficacy and Safety of Clindamycin + Benzoyl Peroxide Formulation With Azelaic Acid Formulation in the Treatment of Acne Vulgaris

NCT02058628 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2017-08-25

Study results available
· View outcomes & findings →

Summary

This is a randomized, comparator-controlled, single-blind, parallel-group study. The current study proposes to compare a fixed-dose combination product containing 3% benzoyl peroxide (BPO) and 1% clindamycin against a cream containing 20% azelaic acid for the treatment of facial acne vulgaris. The results of the study will enable a better assessment of the safety and efficacy of the new dose regime (BPO 3% + clindamycin 1%) in comparison to a well established treatment. Based on the data more evidence based recommendations will be possible to improve the treatment of subjects with acne vulgaris. A total of 220 subjects will be enrolled and will have 5 study visits (Day 1, Weeks 2, 4, 8 and 12). The duration of the study will be over 12 weeks.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Clindamycin + BPO

Gel containing 1.2% clindamycin and 3% BPO for once daily application

DRUG

Azelaic acid

Cream containing 20% azelaic acid for twice daily application

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-02-21
Primary Completion
2014-09-08
Completion
2014-09-08

Countries

  • Germany

Study Locations

More Related Trials

Entities

Companies

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 NCT02058628 on ClinicalTrials.gov