Phase 1
N=42
Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia
Alopecia · Alopecia, Androgenetic · Baldness
Bottom Line
View on ClinicalTrials.gov: NCT01189279 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Aug 2013
Primary outcome: Primary: Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost — 0.552; 1.77; 5.58 Picograms/Milliliter (pg/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- bimatoprost Formulation A (Drug); bimatoprost Formulation B (Drug); bimatoprost Formulation C (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Allergan
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Plasma Level (Cmax) Following a Single Dose of Bimatoprost |
0.552; 1.77; 5.58 | — |
| PRIMARY Maximum Plasma Level (Cmax) Following Multiple Doses of Bimatoprost |
1.26; 3.01; 10.1 | — |
| SECONDARY Percentage of Patients With Clinically Significant Electrocardiogram (ECG) Findings |
0.0; 0.0; 0.0 | — |
| SECONDARY Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Patient Assessment |
0; 0; 0; 1; 0; 1 | — |
| SECONDARY Number of Patients With an at Least 1-Grade Severity Increase in Local Scalp Tolerability by Dermatologist Assessment |
0; 1; 0; 0; 0; 0 | — |
Summary
This study will investigate the safety, tolerability, and pharmacokinetics of new formulation of bimatoprost following topical application in patients with alopecia. Two formulations of bimatoprost will be investigated in Part 1 and a third formulation of bimatoprost will be investigated in Part 2. Part 2 will begin after Part 1 has completed.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01189279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.