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Retin-A Micro 0.04% facial acne treatment

Phase 2

Acne Vulgaris | Small molecule | Dermatology |Bausch Health Companies Inc.|Last Updated: Feb 15, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

Retin-A Micro 0.04% facial acne treatment · 1 trial · 1 indication

Phase 2 1
NCT00907335A Study of Acne Treatment in Children Ages 9 to 11Acne Vulgaris
COMPLETED110 Analytics
PHASE2COMPLETED
A Study of Acne Treatment in Children Ages 9 to 11
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Study Endpoints

Primary Endpoints

Change From Baseline in Total Non-inflammatory Lesion Count
Baseline to Week 12

Change from Baseline to Week 12 (Week 12 minus Baseline) in the total non-inflammatory acne lesion count. Facial acne lesion counts consisted of non-inflammatory lesions and inflammatory lesions. The total non-inflammatory acne lesion count is the sum of open and closed comedones, change from Baseline was calculated as the value after Baseline minus the baseline value, and negative changes indicated lesion improvement.

Secondary Endpoints

Change From Baseline in Lesion Counts
Baseline to Week 12
Measurement of Success 1
Week 12
Measurement of Success 2
Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Retin-A MicroEXPERIMENTALRetin-A Micro 0.04% facial acne treatment used once daily
Vehicle ControlPLACEBO_COMPARATORColor matched facial gel vehicle control used once daily

Interventions

NameTypeDescription
Retin-A Micro 0.04% facial acne treatmentDRUGRetin-A Micro 0.04% facial acne treatment used once daily
Vehicle controlDRUGColor-matched facial gel vehicle control used once daily
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Eligibility Criteria

Age Range9 Years to 11 Years
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Males and non-pregnant, non-nursing females, 9 to 11 years, with facial pediatric acne vulgaris * Minimum of 20 non-inflammatory lesions (open and closed comedones) * Minimum of 30 total facial lesions (sum of inflammatory and non-inflammatory) * Must have at least a rating of...

Countries:United States
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Frequently asked questions about Retin-A Micro 0.04% facial acne treatment

What is Retin-A Micro 0.04% used for in acne vulgaris?

Retin-A Micro 0.04% is a small molecule facial acne treatment being studied for acne vulgaris. It is a topical formulation developed by Bausch Health Companies Inc. (BHC). The drug is currently in Phase 2 clinical development and is not yet approved by the FDA.

What does Retin-A Micro 0.04% target?

Retin-A Micro 0.04% is a retinoid, which works by affecting skin cell turnover and reducing inflammation. It is designed to treat acne vulgaris by unclogging pores and promoting the shedding of dead skin cells. The specific molecular target is not disclosed in the available information.

Who makes Retin-A Micro 0.04%?

Retin-A Micro 0.04% is developed by Bausch Health Companies Inc., a pharmaceutical company traded under the ticker BHC. The company is conducting clinical trials for this acne treatment in the dermatology therapeutic area.

What phase is Retin-A Micro 0.04% in?

Retin-A Micro 0.04% is in Phase 2 clinical development. It is an investigational drug for acne vulgaris and has not received FDA approval. The drug is being studied in a completed Phase 2 trial with 110 participants.

What clinical trials is Retin-A Micro 0.04% in?

Retin-A Micro 0.04% has one completed Phase 2 trial, NCT00907335, titled 'A Study of Acne Treatment in Children Ages 9 to 11'. This randomized, double-blind, placebo-controlled study enrolled 110 participants with acne vulgaris in the United States.

Is Retin-A Micro 0.04% the same as tretinoin?

Retin-A Micro 0.04% is a brand name for a formulation of tretinoin, a retinoid used for acne. It is developed by Bausch Health Companies Inc. and is currently in Phase 2 trials for acne vulgaris in children aged 9 to 11.