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lidamycin and benzoyl peroxide 1.2%/3.75% combination

Phase 2

Actinic Keratosis | Small molecule | Dermatology |Bausch Health Companies Inc.|Last Updated: Sep 4, 2020

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment22

FDA Designations

No designations recorded

Clinical trial landscape

lidamycin and benzoyl peroxide 1.2%/3.75% combination · 1 trial · 1 indication

Phase 2 1
NCT03122457Perimenstrual Acne With Clindamycin Phosphate and Benzoyl PeroxideActinic Keratosis
COMPLETED22 Analytics
PHASE2COMPLETED
Perimenstrual Acne With Clindamycin Phosphate and Benzoyl Peroxide
Actinic KeratosisUnlock trial analytics

Study Endpoints

Primary Endpoints

PGA Score
Day 99

Treatment Success defined as a score of 0 (clear) to 1 (almost clear) at day 99 (final study visit) by acne PGA scoring system. Full PGA scale from 0-5, with lower score indicating better drug efficacy

Secondary Endpoints

Adverse Event Severity
Day 99
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
lidamycin phosphate and benzoyl peroxide 1.2%/3.75% comboEXPERIMENTALlidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination gel; daily use for 99 days

Interventions

NameTypeDescription
lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combinationDRUGAt Day 15, patients will be re-assessed and dispensed the investigational product and instructed on its daily use. Patients will continue to return every 14 days to have their skin assessed until their final visit on day 99, one week after their 3rd menses on treatment (4th menses on study).
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Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Women 18 years or older * Women who have had their first menses at least 12 months ago, and who currently have regular menses. * Subjects must be able to read and understand English, and be able and willing to complete the survey. * Subjects must have a self-reported complaint...

Countries:United States
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