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Encapsulated Benzoyl Peroxide

Phase 1

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

Encapsulated Benzoyl Peroxide target and mechanism

ModalitySmall molecule

Also known as Encapsulated Benzoyl Peroxide Cream

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

Encapsulated Benzoyl Peroxide clinical trials

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?

Encapsulated Benzoyl Peroxide is an investigational small molecule dermatology therapy that Sol-Gel Technologies Ltd. (ticker SLGL) is developing for papulopustular rosacea. It is a topical formulation in which the benzoyl peroxide is encapsulated. It is also known as Encapsulated Benzoyl Peroxide Cream.

What is Encapsulated Benzoyl Peroxide used for?

Encapsulated Benzoyl Peroxide is being studied for papulopustular rosacea, a form of rosacea marked by papules and pustules. The only trial recorded for this asset enrolled adults with that condition. It is investigational and has not been established as a treatment outside of clinical research.

Who makes Encapsulated Benzoyl Peroxide?

Sol-Gel Technologies Ltd. is developing Encapsulated Benzoyl Peroxide. The company trades under the ticker SLGL. Sol-Gel is the sponsor of the clinical program for this topical dermatology asset.

What phase is Encapsulated Benzoyl Peroxide in?

Encapsulated Benzoyl Peroxide is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. It is an investigational product and is not approved for marketing.

What clinical trials is Encapsulated Benzoyl Peroxide in?

Encapsulated Benzoyl Peroxide has been evaluated in one completed Phase 1 trial, NCT05675501, titled Evaluation of Topical Encapsulated Benzoyl Peroxide on the Skin Microbiome and Skin Biophysical Properties. The trial enrolled 31 participants in the United States with papulopustular rosacea and was randomized, double blind, and placebo controlled.

Is Encapsulated Benzoyl Peroxide the same as Encapsulated Benzoyl Peroxide Cream?

Yes. Encapsulated Benzoyl Peroxide Cream is another name for Encapsulated Benzoyl Peroxide, the topical dermatology asset that Sol-Gel Technologies Ltd. (ticker SLGL) is developing for papulopustular rosacea. Both names refer to the same investigational product.