Male Pattern Hair Loss, Androgenetic Alopecia
Conditions
Keywords
male pattern hair loss, androgenetic alopecia, bimatoprost
Brief summary
The purpose of this study is to determine the effect of bimatoprost solution on scalp hair growth. Bimatoprost 0.03% ophthalmic solution is currently approved by the FDA for treatment of glaucoma (Lumigan™) and for thickening of thin eyelashes (Latisse™). Bimatoprost 0.03% is not approved for the treatment of scalp hair loss and its use in this study is considered investigational which means it is still being tested in research studies. Thirty-three subjects were consented and screened, 9 entered and 9 completed the study.
Interventions
DRUGBimatoprost
Bimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug.
DRUGPlacebo
Sponsors
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Hamilton-Norwood patterns of baldness IIIV, IV, V, or VA. 2. Subject's hair color must have adequate contrast against scalp color to allow hair counting on macrophotography. 3. Good health with normal blood tests for hematological, renal, and liver function. 4. Able to return to Duke for study visits.
Exclusion criteria
1. ECOG \>1. 2. Used topical or oral minoxidil in the past 6 months, oral finasteride in the past 12 months or oral dutasteride in the past 24 months. 3. Taken any warfarin, heparin, or retinoid for greater than 2 weeks during the past 6 months and any in the past month. 4. Taken any chemotherapy in the past 2 years. 5. Used any over-the-counter (OTC) preparation that purports to help hair growth in the past four months. 6. Used prostaglandins of any type in the past or currently. 7. Any history of alopecia areata, cicatricial alopecia, radiation to the head, hair transplants, or scalp reductions. 8. Any skin abnormalities in the target area that would effect hair growth. 9. Any history of glaucoma or elevated intraocular pressure (IOP). 10. Any cancer other than non-melanoma skin cancer (NMSC) in the past 2 years and all must be in remission.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Target Area Total Hair Count | Baseline to week 17; and week 17 to week 34 | The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in the Target Area Terminal Hair Count | Baseline to week 17; and week 17 to week 34 | Terminal hairs are those which grow beyond a cm and contribute to overall hair density. |
| Percent Change in the Target Area Vellus Hair Count | Baseline to week 17; and week 17 to week 34 | Vellus hairs are fine hairs that generally do not grow beyond 1 cm and do not contribute to overall hair density. For the most part, they have a diameter of \<40 um. They are increased in number in male pattern baldness |
| Percent Change in Hair Diameter | Baseline to week 17; Week 17 to week 34 | The percent change in hair diameter is a recent addition to the methods of assessing efficacy of hair growth promoters. It is a measure of hair mass and does not separate out the effect on terminal and vellus hairs but rather combines the effect on both. Since it is only terminal hairs that contributes to normal hair density, this measure does not add anything to the measures of total, terminal and vellus hair counts in terms of overall effect on hair growth and is therefore not analyzed or reported here. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Then Bimatoprost Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks. | 3 |
| Bimatoprost Then Placebo Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.
Between Part 1 and Part 2 subjects completed a 10 day washout period.
Part 2: Patients were randomized to apply placebo topically for 16 weeks. | 6 |
| Total | 9 |
Baseline characteristics
| Characteristic | Placebo Then Bimatoprost | Bimatoprost Then Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 6 Participants | 9 Participants |
| Region of Enrollment United States | 3 participants | 6 participants | 9 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 9 |
| serious Total, serious adverse events | 0 / 3 | 0 / 6 |
Outcome results
Primary
Percent Change in Target Area Total Hair Count
The primary endpoint is the percent change in total hair count from the beginning and end of each part of the study.
Time frame: Baseline to week 17; and week 17 to week 34
Population: intention to treat (ITT)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo Then Bimatoprost | Percent Change in Target Area Total Hair Count | Part 1: Baseline to week 17 | -2.6 percentage change in total hair count |
| Placebo Then Bimatoprost | Percent Change in Target Area Total Hair Count | Part 2: week 17 to week 34 | 4.9 percentage change in total hair count |
| Bimatoprost Then Placebo | Percent Change in Target Area Total Hair Count | Part 1: Baseline to week 17 | 27.4 percentage change in total hair count |
| Bimatoprost Then Placebo | Percent Change in Target Area Total Hair Count | Part 2: week 17 to week 34 | -5.8 percentage change in total hair count |
Secondary
Percent Change in Hair Diameter
The percent change in hair diameter is a recent addition to the methods of assessing efficacy of hair growth promoters. It is a measure of hair mass and does not separate out the effect on terminal and vellus hairs but rather combines the effect on both. Since it is only terminal hairs that contributes to normal hair density, this measure does not add anything to the measures of total, terminal and vellus hair counts in terms of overall effect on hair growth and is therefore not analyzed or reported here.
Time frame: Baseline to week 17; Week 17 to week 34
Population: Data not analyzed, and therefore not reported.
Secondary
Percent Change in the Target Area Terminal Hair Count
Terminal hairs are those which grow beyond a cm and contribute to overall hair density.
Time frame: Baseline to week 17; and week 17 to week 34
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo Then Bimatoprost | Percent Change in the Target Area Terminal Hair Count | Part 1: Baseline to week 17 | -2.1 percent change of terminal hair count |
| Placebo Then Bimatoprost | Percent Change in the Target Area Terminal Hair Count | Part 2: week 17 to week 34 | -5.1 percent change of terminal hair count |
| Bimatoprost Then Placebo | Percent Change in the Target Area Terminal Hair Count | Part 1: Baseline to week 17 | 12.1 percent change of terminal hair count |
| Bimatoprost Then Placebo | Percent Change in the Target Area Terminal Hair Count | Part 2: week 17 to week 34 | -8.3 percent change of terminal hair count |
Secondary
Percent Change in the Target Area Vellus Hair Count
Vellus hairs are fine hairs that generally do not grow beyond 1 cm and do not contribute to overall hair density. For the most part, they have a diameter of \<40 um. They are increased in number in male pattern baldness
Time frame: Baseline to week 17; and week 17 to week 34
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Placebo Then Bimatoprost | Percent Change in the Target Area Vellus Hair Count | Part 1: Baseline to week 17; | -2.6 Percent change of vellus hair count |
| Placebo Then Bimatoprost | Percent Change in the Target Area Vellus Hair Count | Part 2: week 17 to week 34 | 5.1 Percent change of vellus hair count |
| Bimatoprost Then Placebo | Percent Change in the Target Area Vellus Hair Count | Part 2: week 17 to week 34 | 2.9 Percent change of vellus hair count |
| Bimatoprost Then Placebo | Percent Change in the Target Area Vellus Hair Count | Part 1: Baseline to week 17; | 78.1 Percent change of vellus hair count |