Evidence map›Paper›PMID 40377868›Full record

ArticleDermatology and therapy2025

Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel: Post Hoc Analysis by Baseline Disease Severity.

Michael Gold, Ted Lain, Julie C Harper, Hilary Baldwin, Eric Guenin, Linda Stein Gold

4 registry-linked trialsAbstract read
In one paragraph

Article in Dermatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03170388 phase2completednot on this map

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2017 to 2019Enrolled741ConditionsAcne VulgarisArmsIDP-126 Gel, IDP-126 Component A, IDP-126 Component B, IDP-126 Component C, IDP-126 Vehicle Gel
NCT04214639 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2020 to 2021Enrolled183ConditionsAcne VulgarisArmsIDP-126 Gel, IDP-126 Vehicle Gel
NCT04214652 phase3completednot on this map

A Phase 3, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2020 to 2021Enrolled180ConditionsAcne VulgarisArmsIDP-126 Gel, IDP-126 Vehicle Gel
NCT04892706 phase2completednot on this map

A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Clinical Study to Compare the Safety and Efficacy of IDP-126 Gel to Epiduo® Forte Gel (0.3% Adapalene/2.5% BPO), in the Treatment of Acne Vulgaris

TypeinterventionalSponsorBausch Health Americas, Inc.Ran2021 to 2022Enrolled686ConditionsAcne VulgarisArmsIDP-126 Gel, IDP-126 Vehicle Gel, Epiduo® Forte Gel
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Michael GoldTennessee Clinical Research Center, 2000 Richard Jones Road, Suite 220, Nashville, TN, 37215, USA. drgold@goldskincare.com.ORCID http://orcid.org/0000-0002-5183-5433
Ted LainAustin Institute for Clinical Research, Austin, TX, USA.
Julie C HarperDermatology and Skin Care Center of Birmingham, Birmingham, AL, USA.
Hilary BaldwinThe Acne Treatment and Research Center, Brooklyn, NY, USA.
Eric GueninOrtho Dermatologics, Division of Bausch Health US, LLC, Bridgewater, NJ, USA.
Linda Stein GoldHenry Ford Hospital, Detroit, MI, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionClindamycin phosphate (CLIN) 1.2%/adapalene (ADAP) 0.15%/benzoyl peroxide (BPO) 3.1% gel (CAB) is the only triple-combination topical approved for acne. These post hoc analyses assessed efficacy and safety of CAB gel compared with component dyads and branded ADAP 0.3%/BPO 2.5% gel in participants stratified by baseline acne severity.

methodsData were pooled from two phase 2 and two phase 3 12-week studies. Participants were randomized to once-daily CAB or vehicle; one phase 2 study included dyad combinations of CAB active ingredients (ADAP/BPO, CLIN/BPO, and CLIN/ADAP) and the other included a head-to-head comparison with branded ADAP 0.3%/BPO 2.5%. Assessments included percent changes from baseline in inflammatory/noninflammatory lesions (IL/NIL) and treatment success (≥ 2-grade reduction from baseline in Evaluator's Global Severity Score [EGSS] and clear/almost clear skin). Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were assessed.

resultsAt week 12, IL reductions in moderate participants (EGSS = 3; n = 1557) were significantly greater with CAB vs vehicle, dyads, and branded ADAP/BPO (77.1% vs 54.1%, 64.4-69.4%, and 72.8%, respectively; P < 0.05, all). IL reductions in severe participants (EGSS = 4; n = 230) were significantly greater with CAB vs vehicle, ADAP/BPO, and CLIN/BPO (74.5% vs 44.4%, 63.9%, and 61.3%; P < 0.05, all), and similar to CLIN/ADAP and branded ADAP/BPO (73.7%/75.4%). IL reductions were greater than NIL. Moderate participants achieved greater treatment success rates with CAB vs vehicle, dyads, or branded ADAP/BPO (53.9% vs 19.5%, 31.5-35.3%, and 38.1%; P ≤ 0.001, all); only CAB- and CLIN/ADAP-treated severe participants had significantly greater rates vs vehicle (30.9% and 34.0% vs 9.0%; P < 0.05). Most TEAEs were of mild to moderate severity. All mean cutaneous safety/tolerability scores were ≤ 1 (1 = mild).

conclusionsCAB demonstrated superior efficacy to three dyads and branded ADAP 0.3%/BPO 2.5% in moderate acne participants, and generally numerically greater efficacy in severe acne participants. To our knowledge, these analyses include data from the only double-blind, vehicle-controlled, head-to-head study.

trial registrationClinicalTrials.gov identifier NCT03170388, NCT04892706, NCT04214639, and NCT04214652.

Indexed as

AcneAdapaleneBenzoyl peroxideClindamycinClindamycin phosphateClinical trialEfficacySafetySeverity

Identifiers

PMID40377868
PMCPMC12126431

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.