Clinical Trials Logo
  1. Home
  2. Alopecia
  3. NCT02676310
  4. Details
NCT02676310 Clinical Trial

Safety, Tolerability, and Pharmacokinetics of Bimatoprost in Men With Androgenetic Alopecia (AGA)

Alopecia Clinical Trial

Official title:
Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Bimatoprost Topical Solution in the Treatment of Androgenetic Alopecia in Men

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02676310
Other study ID # 192024-085
Secondary ID
Status Terminated
Phase Phase 1
First received February 4, 2016
Last updated March 15, 2017
Start date March 2016
Est. completion date March 2017

Study information
Verified date March 2017
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a safety, tolerability, and pharmacokinetics study of bimatoprost in male patients with androgenetic alopecia (AGA).

Recruitment information / eligibility
Status Terminated
Enrollment 53
Est. completion date March 2017
Est. primary completion date January 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 49 Years
Eligibility Inclusion Criteria:

- Mild to moderate male pattern baldness (androgenic alopecia) with ongoing hair loss for at least 1 year

Exclusion Criteria:

- History of Paget's disease, osteoporosis, or bone malignancy

- History of bone fracture within the previous 12 months, except for metatarsal, metacarpal, or skull fractures

- Patient is currently undergoing radiation therapy or anticipates undergoing radiation therapy at any time during the study

- Drug or alcohol abuse within 12 months

- HIV positive

- Received hair transplants or had scalp reductions

- Use of hair weaves, hair extensions or wigs within 3 months

- Application of topical medications, minoxidil or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bimatoprost

Locations
Country Name City State
United States DermResearch, LLC Austin Texas
United States J&S Studies Inc. College Station Texas
United States E&R Research Foundation Lynchburg Virginia

Sponsors (1)
Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of Participants with Treatment Emergent Adverse Events (TEAEs) 42 Days
Primary Change from Baseline in Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale Baseline, 42 Days
Primary Maximum plasma level (Cmax) of bimatoprost and its acid metabolite 31 Days
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04953416 - Fractional Non-ablative Laser for the Treatment of Hair Loss N/A
Completed NCT01929330 - Bioequivalence Study of Dutasteride Five 0.1 mg and One 0.5 mg Soft Gelatin Capsules in Healthy Male Volunteers Phase 1
Recruiting NCT05213936 - Scalp Cooling for Chemotherapy-Induced Alopecia in Patients of Color N/A
Completed NCT02919735 - Efficacy, Safety and Tolerability of CG428 Cutaneous Solution on Chemotherapy Induced Alopecia; Controlled Study (ELAN) Phase 2
Recruiting NCT02591823 - Hair Fall in Patients on Low Dose Methotrexate N/A
Enrolling by invitation NCT01651689 - Hair Counts From Vertical and Horizontal Sections of Scalp Biopsy SPecimens in Thai Population With Alopecia N/A
Completed NCT01189279 - Safety and Pharmacokinetics Study of New Formulation of Bimatoprost in Patients With Alopecia Phase 1
Recruiting NCT01111981 - Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia Phase 4
Terminated NCT01385839 - Efficacy of Hair Transplantation Compared With Hypodermic Needle Irritation in Alopecia Areata N/A
Active, not recruiting NCT03382184 - Fractional Photothermolysis for Hair Follicle Induction Early Phase 1
Not yet recruiting NCT05544448 - In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases N/A
Completed NCT03689452 - The Effect of Platelet Rich Plasma on Non-scarring Alopecia N/A
Recruiting NCT00801086 - Efficacy Study of Tempol to Prevent Hair Loss From Radiotherapy to the Brain Phase 2
Completed NCT06095739 - Study to Investigate the Effectiveness of a Topical Cosmetic Formulation DA-OTC-002 N/A
Completed NCT05587699 - The Parallel Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of CKD-843 A Phase 1
Completed NCT03351322 - ENERGI-F701 for Female Hair Loss Treatment Phase 2
Completed NCT01590238 - Enhancing Hair Density With Platelet Rich Fibrin Matrix (PRFM) Phase 3
Terminated NCT02935569 - Compression Headband Use to Prevent Hair Loss During Whole Brain Radiotherapy N/A
Not yet recruiting NCT01557491 - Hair Regrowth After Bicoronal Incision N/A
Completed NCT00515762 - Prevention of Persistent Alopecia Following Docetaxel by Means of Scalp Cooling Phase 2