Alopecia Clinical Trial
Verified date | November 2015 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This is a safety and efficacy study of bimatoprost in male subjects with androgenic alopecia (AGA).
Status | Completed |
Enrollment | 244 |
Est. completion date | January 2015 |
Est. primary completion date | September 2014 |
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 - Willingness to maintain same hair style, length and hair color during study - Willingness to have micro-dot-tattoo applied to scalp (Stage 2 only) Exclusion Criteria: - 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 - Use of minoxidil (oral or topical) and/or low level light treatment "combs" for hair growth within the last 6 months, or expected use during the study - Application of topical steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) to scalp within 4 weeks |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Allergan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in Target Area Hair Count (TAHC) | TAHC was measured using digital imaging analysis and was reported in terminal hairs/centimeters squared (cm^2). A positive change from Baseline indicated improvement (increase in the number of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the number of terminal hairs). | Baseline, Month 6 | No |
Primary | Percentage of Participants in Each Response Category of the Subject Self Assessment in Alopecia (SSA) Score | The SSA score measured scalp hair growth. Using a 7-point scale, participants answered the Question: "Since the start of the study, the amount of my hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented. | Month 6 | No |
Secondary | Percentage of Participants in Each Response Category of the Investigator Global Assessment (IGA) Score | The investigator compared the participant's scalp hair growth at Month 6 to a photograph of the scalp taken at Baseline and using the 7-point IGA score, the investigator answered the question: "Since the start of the study, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented. | Month 6 | No |
Secondary | Percentage of Participants in Each Response Category of the Global Panel Review (GPR) Score | At the completion of the study, 3 independent dermatologists using the 7-point GPR score compared photographs of the participant's scalp hair growth at Month 6 to Baseline and answered the question: "Compared with the baseline image, the amount of the subject's hair has?": Greatly Increased, Moderately Increased, Slightly Increased, Remained the Same, Slightly Decreased, Moderately Decreased or Greatly Decreased. The percentage of participants in each response category is presented. | Month 6 | No |
Secondary | Change From Baseline in Target Area Hair Width (TAHW) | Digital imaging analysis was used to measure TAHW in millimeters/centimeters squared (mm/cm^2). The diameters of all terminal hairs (individual hairs = 30 microns in width) in the target area were summed and reported together. A positive change from Baseline indicated improvement (increase in the diameter of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the diameter of terminal hairs). | Baseline, Month 6 | No |
Secondary | Change From Baseline in Target Area Hair Darkness (TAHD) | Digital imaging analysis was used to measure TAHD. The darkness of all terminal hairs (individual hairs = 30 microns in width) in the target area were summed and divided by total number of terminal hairs in the same target area and was reported as intensity units. A positive change from Baseline indicated improvement (increase in the darkness of terminal hairs) and a negative change from Baseline indicated worsening (decrease in the darkness of terminal hairs). | Baseline, Month 6 | No |
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 | |
Completed |
NCT06409650 -
To Evaluate Safety and Efficacy of KX-826 in Chinese Female Subjects With Androgenetic Alopecia
|
Phase 2 | |
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 | |
Not yet recruiting |
NCT01557491 -
Hair Regrowth After Bicoronal Incision
|
N/A | |
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 |