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Encapsulated Benzoyl Peroxide

Phase 1

Papulopustular Rosacea | Small molecule | Dermatology |Sol-Gel Technologies Ltd.|Last Updated: Apr 18, 2023

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05675501Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical PropertiesPHASE1 COMPLETED 31 — — Jun 10, 2020Jul 15, 2021Apr 18, 20231 United States
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Study Endpoints
Primary Endpoints
Change in skin microbiome diversity after 8-weeks of treatment compared to baseline
8-weeks

Facial microbiome sampling will be performed on-site by collecting follicular samples as well as utilizing facial swabs.

Change in transepidermal water loss after 8-weeks of treatment compared to baseline.
8-weeks

transepidermal water loss in g/m2/h

Change in stratum corneum hydration after 8-weeks of treatment compared to baseline.
8-weeks

stratum corneum water content (wt%)

Change in sebum excretion rate after 8-weeks of treatment compared to baseline.
8-weeks

sebum production in µg/cm2

Change in colorimeter test after 8-weeks of treatment compared to baseline.
8-weeks

facial L\*a\*b\* values

Secondary Endpoints
Change in skin microbiome diversity after 30 minutes, 1-week, 2-weeks and 4-weeks of treatment compared to baseline
4-weeks
Change in transepidermal water loss after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
4-weeks
Change in stratum corneum hydration after 1-week, 2-weeks and 4-weeks of treatment compared to baseline.
4-weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Study DrugEXPERIMENTALDaily Encapsulated Benzoyl Peroxide (E-BPO) Cream, for 8 weeks (period 1). Subjects will then switch treatments to the vehicle cream for a period of 4 weeks (period 2),
VehiclePLACEBO_COMPARATORDaily Vehicle Cream, for 8 weeks (period 1). Subjects will then switch treatments to the study drug encapsulated E-BPO for a period of 4 weeks (period 2),
Interventions
NameTypeDescription
Encapsulated Benzoyl Peroxide CreamDRUGSubjects will use a "pea-size" amount for each area of the face
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Participants must sign an Institutional Review Board (IRB) approved written informed consent for this study. * Male and female 18 years of age and older. * Participants must have clinical diagnosis of moderate to severe rosacea. * Have a minimum total of 15 and a maximum of 70...

Countries:United States
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