Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02170662
Other study ID # Pro00017573
Secondary ID
Status Completed
Phase Phase 2
First received June 20, 2014
Last updated August 27, 2014
Start date November 2009
Est. completion date May 2011

Study information

Verified date July 2014
Source Duke University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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 (Lumiganā„¢) and for thickening of thin eyelashes (Latisseā„¢). 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.


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date May 2011
Est. primary completion date May 2011
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 45 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Bimatoprost
Bimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug.
Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Duke University

Outcome

Type Measure Description Time frame Safety issue
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. Baseline to week 17; and week 17 to week 34 No
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. Baseline to week 17; and week 17 to week 34 No
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 Baseline to week 17; and week 17 to week 34 No
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. Baseline to week 17; Week 17 to week 34 No
See also
  Status Clinical Trial Phase
Completed NCT02591355 - Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment N/A
Withdrawn NCT03852992 - Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia Phase 2
Recruiting NCT06239207 - Efficacy and Safety of Exosomes Versus Platelet Rich Plasma in Patients of Androgenetic Alopecia Phase 2
Completed NCT04945226 - A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001 Phase 1/Phase 2
Completed NCT01437163 - Treatment of Androgenetic Alopecia in Males and Females N/A
Completed NCT01548066 - The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss Phase 2
Completed NCT01226459 - Clinical Trial in Females for Female Pattern Hair Loss Phase 3
Recruiting NCT06118866 - A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia Phase 2
Completed NCT06149221 - Penetration-enhanced Direct DBD Non-thermal Plasma for Hair Loss N/A
Withdrawn NCT04882969 - Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia N/A
Completed NCT01231607 - Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia Phase 3
Completed NCT04446429 - Anti-Androgen Treatment for COVID-19 N/A
Completed NCT02729415 - Point-of-Care Adipose-derived Cells for Hair Growth N/A
Completed NCT02279823 - A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia Phase 2
Not yet recruiting NCT01227031 - Pharmacogenomic Study of Androgenetic Alopecia N/A
Completed NCT00981461 - Treatment of Androgenetic Alopecia in Females, 9 Beam N/A
Completed NCT01451021 - A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss Phase 2
Completed NCT00151515 - A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss Phase 3
Completed NCT03694067 - Androgenetic Alopecia and the JAK-STAT Pathway
Completed NCT03689452 - The Effect of Platelet Rich Plasma on Non-scarring Alopecia N/A