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Bimatoprost 1

Phase 2

Alopecia | Small molecule | Dermatology |AbbVie Inc.|Last Updated: Mar 22, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment244

FDA Designations

No designations recorded

Clinical trial landscape

Bimatoprost 1 · 1 trial · 3 indications

Phase 2 1
NCT01904721A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)Alopecia
COMPLETED244 Analytics
PHASE2COMPLETED
A Safety and Efficacy Study of Bimatoprost in Men With Androgenic Alopecia (AGA)
AlopeciaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Target Area Hair Count (TAHC)
Baseline, Month 6

TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm\^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs).

Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score
Month 6

The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented.

Secondary Endpoints

Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score
Month 6
Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score
Month 6
Change From Baseline in Target Area Hair Width (TAHW)
Baseline, Month 6
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Stage 1: Bimatoprost Solution 1 Twice DailyEXPERIMENTALStage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
Stage 1: Bimatoprost Solution 1 Once DailyEXPERIMENTALStage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
Stage 1: Bimatoprost Solution 2 Twice DailyEXPERIMENTALStage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
Stage 1: Bimatoprost Solution 2 Once DailyEXPERIMENTALStage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
Stage 2: Bimatoprost Solution 1 Twice DailyEXPERIMENTALStage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Solution 2 Twice DailyEXPERIMENTALStage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
Stage 2: Bimatoprost Vehicle Twice DailyPLACEBO_COMPARATORStage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.

Interventions

NameTypeDescription
Bimatoprost Solution 1DRUGBimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Bimatoprost Solution 2DRUGBimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
Bimatoprost VehicleDRUGBimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
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Eligibility Criteria

Age Range18 Years to 49 Years
SexMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year * Willingness to maintain same hair style, length and hair color during study * Willingness to have micro-dot-tattoo applied to scalp (Stage 2 only) Exclusion Criteria: * ...

Countries:United States
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Frequently asked questions about Bimatoprost 1

What is Bimatoprost used for?

Bimatoprost is used for glaucoma, open-angle glaucoma, ocular hypertension, eyebrow hypotrichosis, and alopecia. It is a small molecule developed by AbbVie Inc. for ophthalmology and related conditions. In clinical trials, it has been studied for open-angle glaucoma, ocular hypertension, and androgenic alopecia.

How does Bimatoprost work?

Bimatoprost is a prostaglandin analog that lowers intraocular pressure by increasing the outflow of aqueous humor through the uveoscleral pathway. It is used in ophthalmology for conditions like open-angle glaucoma and ocular hypertension. The drug is also studied for effects on hair growth in conditions such as alopecia.

Who makes Bimatoprost?

Bimatoprost is developed by AbbVie Inc., a biopharmaceutical company traded on the NYSE under the ticker ABBV. AbbVie conducts clinical trials for the drug across multiple indications, including glaucoma and alopecia.

What phase is Bimatoprost in?

Bimatoprost is in Phase 3 clinical development. It has completed four trials, including Phase 3 studies for open-angle glaucoma and ocular hypertension. The drug is investigational and not yet approved for these uses, though it is also studied for other conditions.

What clinical trials is Bimatoprost in?

Bimatoprost has completed four clinical trials, including NCT03850782, NCT03891446, and NCT04285580 for open-angle glaucoma and ocular hypertension, and NCT01904721 for androgenic alopecia. These trials enrolled a total of 2067 participants across multiple countries.

Is Bimatoprost the same as Latisse?

Bimatoprost is the active ingredient in Latisse, a treatment for eyebrow hypotrichosis. It is also used for glaucoma and ocular hypertension. The drug is developed by AbbVie Inc. and is being studied for additional indications like alopecia.