Minoxidil 5% / Botanical Hair Regimen in Men With Thinning Hair and Male Pattern Hair Loss/Androgenic Alopecia

NCT02460289 | Completed Results

• 1 other identifier: GLI.04.SPR.US 10329
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to characterize the effect of Minoxidil 5% Foam and Botanical Hair Solution Regimen in men with thinning hair and male pattern hair loss/androgenic alopecia (Norwood III \& IV).

Conditions

Male Pattern of Hair Loss, Androgenic Alopecia

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Investigator's Rating of Standardized Global Photographs at Week 12

  The Investigator or a trained grader rated each participant's standardized global photographs for improvement from baseline for parameters like hair thinning, hair growth, impression of scalp hair coverage and overall perception of treatment benefit using a 1-to-7-point Likert scale. Investigator global photograph rating were assessed using 7-point Likert scale. Each score on the individual scale ranged from 1 (minimum) to 7 (maximum), that is, (1) Entirely Disagree; (2) Mostly Disagree; (3) Somewhat Disagree; (4) Neither Agree nor Disagree; (5) Somewhat Agree; (6) Mostly Agree; (7) Entirely Agree.

  At Week 12

• Change From Baseline in Participant Rating at Week 12

  Participants rated the parameters like appearance of hair, growth of hair, satisfaction with hairline at the front of the head, satisfaction with hair on the top of the head and satisfaction with hair overall as an overall improvement from the baseline by conducting their own assessments by looking in a mirror and evaluating improvement from baseline using a 1 to 7-point Likert scale. Each score on the individual scale ranged from 1 (minimum) to 7 (maximum), that is, (1) Entirely Disagree; (2) Mostly Disagree; (3) Somewhat Disagree; (4) Neither Agree nor Disagree; (5) Somewhat Agree; (6) Mostly Agree; (7) Entirely Agree.

  At Week 12

Secondary Outcomes (2)

• Mean Change From Baseline in Shed Hair Count

  At Week 12

• Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire

  At Week 4,6 and 12

Other Outcomes (1)

• Number of Participants With Adverse Events (AEs)

  From start of study up to Week 12

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: Treatment: Minoxidil 5% / Botanical Hair Solution for Men

Interventions

Treatment: Minoxidil 5% / Botanical Hair Solution for Men DRUG

Treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male patients age 18 to 60 years at the time of enrollment.
• Men who have self-perceived thinning hair.
• Men who have presentation of male pattern hair loss/androgenic alopecia (Norwood III \& IV).

You may not qualify if:

• History of allergic reactions or severe intolerance to minoxidil and Botanical Hair Solution product ingredients.
• Plan to use any other concomitant therapy to treat hair loss, regrowth or volume during the study.
• Subjects taking or planning to take topical or systemic prescription or OTC medications for treating hair loss and/or hair volume.
• \. Any significant history of concurrent medical disease, which in the judgment of the Investigator, would make the subject inappropriate for entry to this study including history of skin disease that may confound study results.

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (1)

Stephens & Associates

Richardson, Texas, 75081, United States

Location

MeSH Terms

Conditions

Alopecia

Interventions

Menogaril

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nogalamycin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Results Point of Contact

• Title: Clinical Operations
• Organization: Galderma

Clinical.Studies@galderma.com

817 961 5000

Study Officials

• Warren Winkelman, MD, PhD, MBA

  Galderma R&D

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2015
• First Posted: June 2, 2015
• Study Start: May 19, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: August 1, 2023
• Results First Posted: August 1, 2023

Record last verified: 2023-07

Locations

US (1)