Androgenetic Alopecia
Conditions
Brief summary
This study will evaluate the skin pharmacokinetics and tolerability of bimatoprost Formulation A and Formulation B following 14 days of once daily topical administration in male participants with androgenetic alopecia (AGA).
Detailed description
Single-center, multiple-dose study evaluting the local pharmacokinetics and tolerability of bimatoprost following 14 days of once daily topical administration of bimatoprost Formulation A and Formulation B (both containing 1% bimatoprost) to the scalp of male patients With androgenetic alopecia
Interventions
DRUGBimatoprost 1% Formulation A
Bimatoprost 1% Formulation A solution applied to the scalp and trunk once daily for 14 days.
DRUGBimatoprost 1% Formulation B
Bimatoprost 1% Formulation B solution applied to the scalp and trunk once daily for 14 days.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
-Patients with mild to moderate Androgenetic Alopecia of the vertex area of the scalp.
Exclusion criteria
* Patients with uncontrolled systemic disease * History of significant cardiovascular disease * Scarring disease, infection, or abnormality of the scalp or hair shaft or systemic disease that could cause temporary hair loss (eg, seborrheic dermatitis, psoriatic dermatitis, alopecia areata, cicatricial alopecia, uncontrolled hyperthyroidism/hypothyroidism, tinea infections, and genetic disorders) * Patients who have received hair transplants or have had scalp reductions * Abnormal bone biomarker laboratory results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drug Concentration in Skin Biopsy Samples | Day 14 |
| Percentage of Participants with at Least 1 Treatment Emergent Adverse Event | 28 Days |
Countries
United States
Outcome results
None listed