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NCT02524665
U0289-404: An Evaluator Blinded, 8 Week, Split Face Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITYII and MURAD in Subjects With Acne
Phase 4 trial testing MAXCLARITY II (2.5% BPO) Foam Cleanser in Acne Vulgaris in 20 participants. Completed in 1 December 2009.
1 December 2009
Quick facts
| Lead sponsor | Stiefel, a GSK Company |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 20 |
| Start date | 1 September 2009 |
| Primary completion | 1 December 2009 |
| Estimated completion | 1 December 2009 |
Drugs / interventions tested
- MAXCLARITY II (2.5% BPO) Foam Cleanser — full drug profile →
- MAXCLARITY II (2.5% BPO) Foam Treatment — full drug profile →
- MAXCLARITY II (0.5% Salicylic Acid) Toner Foam — full drug profile →
- MURAD Clarifying Cleanser (1.5% SA)
- Exfoliating Acne Treatment Gel (1% SA)
- Skin Perfecting Lotion
Conditions studied
- Acne Vulgaris — all drugs for Acne Vulgaris →
Sponsor
Stiefel, a GSK Company — full company profile →
Who can join
Adults 16 to 29, any sex, with Acne Vulgaris. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Mean Percent Change in Inflammatory, Non-inflammatory and Total Lesion Counts From Baseline to Week 8.
Time frame: Baseline and Week 8
During each study visit, expert grader (blinded evaluator) assessed the left side and right side of the face as inflammatory (papules \[solid elevation of skin with no visible fluid\] and pustules \[small inflamed elevation of the skin that is filled with pus\]) and non-inflammatory (open \[blackheads\] and closed \[whiteheads\] comedones) and total lesions for each participant. Each type of lesio
Sponsor's own description
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 product lines for the treatment of acne: MAXCLARITY II Foam Cleanser (2.5% benzoyl peroxide \[BPO\]) plus Foam Treatment (2.5% BPO) and (0.5% Salicylic Acid) Toner Foam compared with MURAD Clarifying Cleanser (1.5% salicylic acid \[SA\]) plus Exfoliating Acne Treatment Gel (1% SA) and Skin Perfecting Lotion.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Topical benzoyl peroxide for acne.
Yang Z, Zhang Y, Lazic Mosler E, Hu J, et al · · 2020 · cited 29× · PMID 32175593 · DOI 10.1002/14651858.cd011154.pub2
Verify or expand the search:
- PubMed search for NCT02524665
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MAXCLARITY II (2.5% BPO) Foam Cleanser
Trials testing the same drug.
- NCT01706250 — U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PRO · Phase 4 · completed
- NCT01706263 — U0289-402: An Open Label, 8 Week Study to Evaluate the Efficacy and Tolerability of MAXCLARITY II in Subjects With Acne · Phase 4 · completed
Other recruiting trials for Acne Vulgaris
Currently open trials in the same condition.
- NCT07341087 — Skin Inflammation in Perimenopause: A Probiotic Intervention Proof of Concept Trial · NA · recruiting
- NCT07474883 — Efficacy of 0.5% Topical Timolol Eye Drops in the Treatment of Post-Inflammatory Erythema Following Acne Vulgaris · EARLY_PHASE1 · recruiting
- NCT07186413 — A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne · Phase 3 · recruiting
- NCT07056673 — Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris Study · NA · recruiting
- NCT07102186 — Efficacy and Safety of Adapalene Gel and Hyaluronic Acid Versus Adapalene Gel Alone in Mild to Moderate Acne Vulgaris · Phase 4 · recruiting
Other Stiefel, a GSK Company trials
Trials by the same sponsor.
- NCT02673619 — A Study to Evaluate Clinical Effect, Pharmacokinetics , Safety, and Tolerability of Umeclidinium in Palmar Hyperhidrosis · Phase 2 · completed
- NCT02411162 — A Single Dose Phase I Exploratory Study in Healthy Volunteers With GSK2894512 Cream · Phase 1 · completed
- NCT02014584 — Sexual Function in Men Receiving Dutasteride for Androgenetic Alopecia · Phase 3 · completed
- NCT01984775 — A Study to Evaluate the Irritation Potential of GSK2894512 Cream on Skin in Healthy Subjects · Phase 1 · completed
- NCT01446237 — U0289-405: An Open-Label, 12-Week Study to Evaluate the Efficacy and Safety of the Acne System (Benzoyl Peroxide 2.5%, S · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02524665 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Stiefel, a GSK Company
- Last refreshed: 16 March 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02524665.
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