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U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™

NCT01706250 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-08-23

Study results available
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Summary

One of the main success factors in acne therapy is user compliance with treatment, product cost, availability and ease of use. Poor compliance may translate into decreased efficacy (either not improving symptoms well enough or not improving symptoms fast enough), tolerability issues or adverse effects (eg, erythema, dryness, or peeling of the skin), a lack of understanding of the instructions for use, or product cost/availability. Whatever the reason, poor compliance translates to decreased efficacy and increased frustration on the part of the user.

The current study will evaluate and compare the efficacy and tolerability of 2 over-the-counter, topical benzoyl peroxide (BPO) product lines in subjects with acne: MAXCLARITY II (2.5% BPO) Foam Cleanser and Foam Treatment and (0.5% Salicylic Acid) Toner Foam compared with PROACTIV (2.5% BPO) Renewing Cleanser and Repairing Lotion and Revitalizing Toner.

Conditions

  • Acne Vulgaris

Interventions

OTHER

MAXCLARITY II (2.5% BPO) Foam Cleanser

Available over the counter.

OTHER

MAXCLARITY II (2.5% BPO) Foam Treatment

Available over the counter.

OTHER

MAXCLARITY II (0.5% Salicylic Acid) Toner Foam

Available over the counter.

OTHER

PROACTIV (2.5% BPO) Renewing Cleanser

Available over the counter.

OTHER

PROACTIV (2.5% BPO) Repairing Lotion

Available over the counter.

OTHER

PROACTIV (2.5% BPO) Revitalizing Toner

Available over the counter.

Sponsors & Collaborators

  • Stiefel, a GSK Company

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
29 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-01
Primary Completion
2010-01-01
Completion
2010-01-25

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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 NCT01706250 on ClinicalTrials.gov