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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

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

Encapsulated Benzoyl Peroxide · 1 trial · 1 indication

Phase 1 1
NCT05675501Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical PropertiesPapulopustular Rosacea
COMPLETED31 Analytics
PHASE1COMPLETED
Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties
Papulopustular RosaceaUnlock trial analytics

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 to 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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Frequently asked questions about Encapsulated Benzoyl Peroxide

What is Encapsulated Benzoyl Peroxide used for?

Encapsulated Benzoyl Peroxide is an investigational small molecule being developed for the treatment of papulopustular rosacea, a form of rosacea characterized by redness and pus-filled bumps. It is applied topically and is currently in Phase 1 clinical development.

Who makes Encapsulated Benzoyl Peroxide?

Encapsulated Benzoyl Peroxide is being developed by Sol-Gel Technologies Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SLGL. The company is conducting clinical research on this topical treatment for papulopustular rosacea.

What phase is Encapsulated Benzoyl Peroxide in?

Encapsulated Benzoyl Peroxide is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains under evaluation for papulopustular rosacea.

What clinical trials is Encapsulated Benzoyl Peroxide in?

Encapsulated Benzoyl Peroxide has one completed clinical trial, NCT05675501, titled "Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties." This Phase 1 study enrolled 31 participants with papulopustular rosacea in the United States.

Is Encapsulated Benzoyl Peroxide the same as benzoyl peroxide?

Encapsulated Benzoyl Peroxide is a formulation of benzoyl peroxide, a common acne treatment, designed for topical use in papulopustular rosacea. The encapsulation technology aims to deliver the active ingredient in a controlled manner, but it is not a different chemical entity.