Evidence map›Paper›PMID 34674160›Full record

Trial reportAmerican journal of clinical dermatology2022

Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel for Moderate-to-Severe Acne: A Randomized Phase II Study of the First Triple-Combination Drug.

Linda Stein Gold, Hilary Baldwin, Leon H Kircik, Jonathan S Weiss, David M Pariser, Valerie Callender, Edward Lain, Michael Gold, Kenneth Beer, Zoe Draelos and 4 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in American journal of clinical dermatology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 18 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 2 pooled it
5.6field-weighted citation impact, top 4% of its field
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
NCT07421804 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Clinical and Microbiological Evaluation of Topical Dutasteride as a Potential New Therapy of Facial Acne Vulgaris Versus the Triple Combination Therapy (Clindamycin Phosphate 1.2%, Benzoyl Peroxide 3.1%, and Adapalene 0.15% Gel)

TypeinterventionalSponsorAssiut UniversityRan2026 to 2028Enrolled50ConditionsAcne VulgarisArmstopical dutasteride
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.

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  12. Clindamycin: A Comprehensive Status Report with Emphasis on Use in Dermatology.The Journal of clinical and aesthetic dermatology · 2024
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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

14 authors at 13 institutions in 1 country.

Linda Stein GoldHenry Ford Hospital, 6530 Farmington Rd, Ste 101, West Bloomfield, Detroit, MI, 48322, USA. LSTEIN1@hfhs.org.
Hilary BaldwinThe Acne Treatment and Research Center, Brooklyn, NY, USA.
Leon H KircikIndiana University School of Medicine, Indianapolis, IN, USA.
Jonathan S WeissGeorgia Dermatology Partners, Snellville, GA, USA.
David M PariserEastern Virginia Medical School, Norfolk, VA, USA.
Valerie CallenderCallender Dermatology and Cosmetic Center, Glenn Dale, MD, USA.
Edward LainAustin Institute for Clinical Research, Austin, TX, USA.
Michael GoldTennessee Clinical Research Center, Nashville, TN, USA.
Kenneth BeerUniversity of Miami Miller School of Medicine, Miami, FL, USA.
Zoe DraelosDermatology Consulting Services, PLLC, High Point, NC, USA.
Neil SadickWeill Cornell Medical College, New York, NY, USA.
Radhakrishnan PillaiBausch Health US, LLC, Petaluma, CA, USA.
Varsha BhattBausch Health US, LLC, Petaluma, CA, USA.
Emil A TanghettiCenter for Dermatology and Laser Surgery, Sacramento, CA, USA.
Bausch Health (United States) · USCenter for Dermatology and Laser Surgery · USDermatology Consulting Services · USEastern Virginia Medical School · USGwinnett Dermatology · USHenry Ford Hospital · USHouston Institute for Clinical Research · USHoward University · USIndiana University School of MedicineRobert Wood Johnson University Hospital · USSadick Dermatology · USTennessee Clinical Research Center · USUniversity of Miami · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA three-pronged approach to acne treatment-combining an antibiotic, antibacterial, and retinoid-could provide greater efficacy and tolerability than single or dyad treatments, while potentially improving patient compliance and reducing antibiotic resistance.

objectivesWe aimed to evaluate the efficacy and safety of triple-combination, fixed-dose topical clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.1%/adapalene 0.15% (IDP-126) gel for the treatment of acne.

methodsIn a phase II, double-blind, multicenter, randomized, 12-week study, eligible participants aged ≥ 9 years with moderate-to-severe acne were equally randomized to once-daily IDP-126, vehicle, or one of three component dyad gels: BPO/adapalene; clindamycin phosphate/BPO; or clindamycin phosphate/adapalene. Coprimary endpoints were treatment success at week 12 (participants achieving a ≥ 2-grade reduction from baseline in Evaluator's Global Severity Score and clear/almost clear skin) and least-squares mean absolute changes from baseline in inflammatory and noninflammatory lesion counts to week 12. Treatment-emergent adverse events and cutaneous safety/tolerability were also assessed.

resultsA total of 741 participants were enrolled. At week 12, 52.5% of participants achieved treatment success with IDP-126 vs vehicle (8.1%) and dyads (range 27.8-30.5%; P ≤ 0.001, all). IDP-126 also provided significantly greater absolute reductions in inflammatory (29.9) and noninflammatory (35.5) lesions compared with vehicle or dyads (range inflammatory, 19.6-26.8; noninflammatory, 21.8-30.0; P < 0.05, all), corresponding to > 70% reductions with IDP-126. IDP-126 was well tolerated, with most treatment-emergent adverse events of mild-to-moderate severity.

conclusionsOnce-daily treatment with the novel fixed-dose triple-combination clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15% gel demonstrated superior efficacy to vehicle and all three dyad component gels, and was well tolerated over 12 weeks in pediatric, adolescent, and adult participants with moderate-to-severe acne. CLINICAL

trial registrationClinicalTrials.gov identifier NCT03170388 (registered 31 May, 2017).

Indexed as

Acne VulgarisAdapaleneAdministration, TopicalAdolescentAdultBenzoyl PeroxideChildClindamycinDermatologic AgentsDouble-Blind MethodDrug CombinationsFemaleHumansMaleMiddle AgedYoung AdultAdapaleneBenzoyl PeroxideClindamycinclindamycin phosphateDermatologic AgentsDrug Combinations

Identifiers

PMID34674160
PMCPMC8776677
OpenAlexW3206427606

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.