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

Multicenter, Open Label Clinical Trial to Evaluate the Effect and Tolerability of Minoxidil 5% Foam and Botanical Hair Solution Regimen in Men With Thinning Hair and Male Pattern of Hair Loss/Androgenic Alopecia (Norwood III & IV)

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).

Study Overview

• Status: Completed
• Conditions: Male Pattern of Hair Loss, Androgenic Alopecia
• Intervention / Treatment: Drug: Treatment: Minoxidil 5% / Botanical Hair Solution for Men

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75081
      • Stephens & Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

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

Key Exclusion Criteria:

1. History of allergic reactions or severe intolerance to minoxidil and Botanical Hair Solution product ingredients.
2. Plan to use any other concomitant therapy to treat hair loss, regrowth or volume during the study.

3 Subjects taking or planning to take topical or systemic prescription or OTC medications for treating hair loss and/or hair volume.

4. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment	Drug: Treatment: Minoxidil 5% / Botanical Hair Solution for Men

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change From Baseline in Shed Hair Count	Participants collected their hair full day, including after combing and hair-washing. Participants turned in these hair collections at each visit. The results were averaged weekly. Mean change from baseline in hair wash/shed hair count was reported at Week 12.	At Week 12
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire	Participant's satisfaction questionnaire was used to specifically collect the participants' feedback on the treatment regimen, the level of satisfaction and future usage. Participants were asked to complete a cosmetic acceptability questionnaire. This 10 item questionnaire had a 5-point Likert Response Scale (1=Strongly Agree; 5=Strongly Disagree).	At Week 4,6 and 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs)	AEs were defined as any untoward medical occurrence associated with the use of a study product in humans, whether or not considered study product related. An AE could be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study product and would not imply any judgment about causality. An AE could arise with any use of the study product and with any route of administration, formulation, or dose, including an overdose. Thus, any new sign, symptom or disease, or clinically significant increase in the intensity of an existing sign, or symptom would be considered as an AE. Any new clinically relevant sign or symptom suffered by the participant, which appeared after the study procedures was reported as an AE. Any worsening in scalp dryness or itch score from baseline was also reported as an AE. The Investigator or designee had the final authorization to determine if a reaction was considered an AE.	From start of study up to Week 12

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Study Director: Warren Winkelman, MD, PhD, MBA, Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: May 29, 2015
• First Submitted That Met QC Criteria: May 29, 2015
• First Posted (Estimated): June 2, 2015

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata; Antihypertensive Agents; Vasodilator Agents; Minoxidil
• Other Study ID Numbers: GLI.04.SPR.US 10329