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Clindamycin 1%-Benzoyl Peroxide 3%

Phase 1

Acne Vulgaris | Small molecule | Dermatology |GSK plc|Last Updated: Jun 16, 2017

Target and mechanism

ModalitySmall molecule

Also known as Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment72

FDA Designations

No designations recorded

Clinical trial landscape

Clindamycin 1%-Benzoyl Peroxide 3% · 1 trial · 1 indication

Phase 1 1
NCT01132443W0261-101: A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzoyl Peroxide 5%) in Subjects With AcneAcne Vulgaris
COMPLETED72 Analytics
PHASE1COMPLETED
W0261-101: A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzoyl Peroxide 5%) in Subjects With Acne
Acne Vulgaris
NCT0113244372
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Study Endpoints

Primary Endpoints

Clindamycin plasma concentrations
Baseline to Day 6

Plasma concentrations of clindamycin in subjects with acne vulgaris

Secondary Endpoints

Clindamycin sulfoxide plasma concentrations
Baseline/Day 1, Day 2, 3, 4, and 5 (pre-dose and 1, 2, 4, 6, 8, 12, and 24 hours post dost - Day 6)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,EXPERIMENTALApply topically once daily; clindamycin (CLN); benzoyl peroxide (BPO); methylparaben-free (MPF)
Duac/ formulation 1ACTIVE_COMPARATORApply topically once daily, Topical Gel (CLN 1%-BPO 5%), methylparaben-preserved
Duac/ formulation 2ACTIVE_COMPARATORApply topically once daily, Duac Once Daily Gel (CLN 1%-BPO 5%), MPF

Interventions

NameTypeDescription
Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,DRUGApply topically once daily
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Eligibility Criteria

Age Range12 Years to 45 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Capable of understanding and willing to provide signed and dated written voluntary informed consent (and HIPAA authorization) before any protocol-specific procedures were performed. Subjects under the legal age of consent in the state where the study was conducted must have pr...

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