Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia
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ClinicalTrials.gov Identifier: NCT01189279 |
Recruitment Status :
Completed
First Posted : August 26, 2010
Results First Posted : August 30, 2013
Last Update Posted : August 30, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Alopecia Alopecia, Androgenetic Baldness | Drug: bimatoprost Formulation A Drug: bimatoprost Formulation B Drug: bimatoprost Formulation C | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | February 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Part 1: bimatoprost Formulation A
bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
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Drug: bimatoprost Formulation A
bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17. |
Experimental: Part 1: bimatoprost Formulation B
bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
|
Drug: bimatoprost Formulation B
bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17. |
Experimental: Part 2: bimatoprost Formulation C
bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
|
Drug: bimatoprost Formulation C
bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17. |
- Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost [ Time Frame: Day 1 ]Cmax is the maximum plasma level following a single dose of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.
- Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost [ Time Frame: 17 Days ]Cmax is the maximum plasma level following multiple doses of bimatoprost. Plasma is the fluid portion of the blood in which the cells are suspended.
- Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings [ Time Frame: 17 Days ]An ECG is a tracing of the heart's electrical activity over time in waves with points identified at P, Q, R, S, and T [measured in milliseconds (ms)], as well as the heart rate [measured in beats per minute (bpm)]. Clinically significant abnormal results include maximum post-treatment QTcB>500 ms, maximum post-treatment QTcF>500 ms, maximum post-treatment QT interval >500 ms, PR interval 25% increase from baseline and >200 ms, QRS interval 25% increase from baseline and >100 ms, heart rate 25% increase from baseline and >100 bpm, and heart rate 25% decrease from baseline and <50 bpm.
- Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment [ Time Frame: Baseline, 20 Days ]Local scalp tolerability by patient assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 3 symptoms (burning, itching, and stinging). An at least 1-grade increase from baseline at any timepoint indicates a worsening of symptoms.
- Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment [ Time Frame: Baseline, 20 Days ]Local scalp tolerability by dermatologist assessment is based on a 4-point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe) for 5 symptoms (dryness/scaling, edema, erythema, folliculitis, and pigmentation). An at least 1-grade increase at any timepoint from baseline indicates a worsening of symptoms.

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Ages Eligible for Study: | 18 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males with moderate male-pattern baldness (androgenic alopecia)
- Females with moderate female pattern hair loss
- Non-smoker or smoker with at least 30 days abstinence from smoking/using nicotine-containing products
Exclusion Criteria:
- Any dermatological condition of the scalp other than androgenic alopecia (males) or female pattern hair loss (females)
- Use of bimatoprost or other prostaglandin analogs within 3 months
- Prior use of scalp hair growth treatment (eg, finasteride, minoxidil) within 6 months
- Any prior hair growth procedures (eg, hair transplant or laser)
- Blood donation or equivalent blood loss within 90 days
- History of alcohol or drug addiction

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01189279
United States, Arizona | |
Tempe, Arizona, United States |
Study Director: | Medical Director | Allergan |
Responsible Party: | Allergan |
ClinicalTrials.gov Identifier: | NCT01189279 |
Other Study ID Numbers: |
192024-053 |
First Posted: | August 26, 2010 Key Record Dates |
Results First Posted: | August 30, 2013 |
Last Update Posted: | August 30, 2013 |
Last Verified: | June 2013 |
Alopecia Alopecia Areata Hypotrichosis Hair Diseases |
Skin Diseases Pathological Conditions, Anatomical Bimatoprost Antihypertensive Agents |