Trial Outcomes & Findings for Minoxidil 5% / Botanical Hair Regimen in Men With Thinning Hair and Male Pattern Hair Loss/Androgenic Alopecia (NCT NCT02460289)

Last Updated: 2023-08-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

63 participants

Primary outcome timeframe

At Week 12

Results posted on

2023-08-01

Participant Flow

The study was conducted in the United States from 19 May 2015 to 19 September 2015.

Participant milestones

Participant milestones
Measure	Minoxidil 5% Foam and Botanical Hair Solution for Men Participant were applied with minoxidil 5% foam on the scalp in the hair loss and botanical hair solution (5-10 sprays) for men on entire scalp (wet or dry) twice per day for 12 weeks.
Overall Study STARTED	63
Overall Study Intent to Treat (ITT) Population	56
Overall Study Safety Population (SP)	61
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Minoxidil 5% Foam and Botanical Hair Solution for Men Participant were applied with minoxidil 5% foam on the scalp in the hair loss and botanical hair solution (5-10 sprays) for men on entire scalp (wet or dry) twice per day for 12 weeks.
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	8
Overall Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Minoxidil 5% Foam and Botanical Hair Solution for Men n=61 Participants Participant were applied with minoxidil 5% foam on the scalp in the hair loss and botanical hair solution (5-10 sprays) for men on entire scalp (wet or dry) twice per day for 12 weeks.
Age, Continuous	45.1 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	6 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	11 Participants n=5 Participants
Race/Ethnicity, Customized White	37 Participants n=5 Participants
Fitzpatrick Skin Type II	6 Participants n=5 Participants
Fitzpatrick Skin Type III	32 Participants n=5 Participants
Fitzpatrick Skin Type IV	18 Participants n=5 Participants
Fitzpatrick Skin Type V	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Week 12

Population: ITT population included all participants who were randomized and have at least one post-treatment administration evaluation.

Outcome measures

Outcome measures
Measure	Minoxidil 5% Foam and Botanical Hair Solution for Men n=56 Participants Participant were applied with minoxidil 5% foam on the scalp in the hair loss and botanical hair solution (5-10 sprays) for men on entire scalp (wet or dry) twice per day for 12 weeks.
Change From Baseline in Investigator's Rating of Standardized Global Photographs at Week 12 Hair Thinning	5.0 Score on a scale Standard Deviation 0.9
Change From Baseline in Investigator's Rating of Standardized Global Photographs at Week 12 Hair Growth	5.1 Score on a scale Standard Deviation 0.9
Change From Baseline in Investigator's Rating of Standardized Global Photographs at Week 12 Impression of scalp hair coverage	5.1 Score on a scale Standard Deviation 0.9
Change From Baseline in Investigator's Rating of Standardized Global Photographs at Week 12 Overall perception of treatment benefit	5.1 Score on a scale Standard Deviation 0.9

PRIMARY outcome

Timeframe: At Week 12

Population: lIT population included all participants who were randomized and had at least one post-treatment administration evaluation.

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.

Outcome measures

Outcome measures
Measure	Minoxidil 5% Foam and Botanical Hair Solution for Men n=56 Participants Participant were applied with minoxidil 5% foam on the scalp in the hair loss and botanical hair solution (5-10 sprays) for men on entire scalp (wet or dry) twice per day for 12 weeks.
Change From Baseline in Participant Rating at Week 12 Appearance of hair	5.4 Score on a scale Standard Deviation 1.2
Change From Baseline in Participant Rating at Week 12 Growth of hair	5.3 Score on a scale Standard Deviation 1.3
Change From Baseline in Participant Rating at Week 12 Satisfaction with hairline at the front of the head	4.9 Score on a scale Standard Deviation 1.4
Change From Baseline in Participant Rating at Week 12 Satisfaction with hair on the top of the head	5.0 Score on a scale Standard Deviation 1.5
Change From Baseline in Participant Rating at Week 12 Satisfaction with hair overall as an overall improvement	5.2 Score on a scale Standard Deviation 1.4

SECONDARY outcome

Timeframe: At Week 12

Population: lTT population included all participants who were randomized and had at least one post-treatment administration evaluation.

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.

Outcome measures

Outcome measures
Measure	Minoxidil 5% Foam and Botanical Hair Solution for Men n=56 Participants Participant were applied with minoxidil 5% foam on the scalp in the hair loss and botanical hair solution (5-10 sprays) for men on entire scalp (wet or dry) twice per day for 12 weeks.
Mean Change From Baseline in Shed Hair Count	14.1 Shed Hair Count Standard Deviation 21.6

SECONDARY outcome

Timeframe: At Week 4,6 and 12

Population: lTT population included all participants who were randomized and had at least one post-treatment administration evaluation.

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).

Outcome measures

Outcome measures
Measure	Minoxidil 5% Foam and Botanical Hair Solution for Men n=56 Participants Participant were applied with minoxidil 5% foam on the scalp in the hair loss and botanical hair solution (5-10 sprays) for men on entire scalp (wet or dry) twice per day for 12 weeks.
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with appearance of hair (At Week 4) · Agree	27 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with appearance of hair (At Week 4) · Disagree	8 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with appearance of hair (At Week 4) · Neutral	21 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with appearance of hair (At Week 6) · Agree	42 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with appearance of hair (At Week 6) · Disagree	4 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with appearance of hair (At Week 6) · Neutral	10 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with appearance of hair (At Week 12) · Agree	44 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with appearance of hair (At Week 12) · Disagree	4 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with appearance of hair (At Week 12) · Neutral	8 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with growth of hair (At Week 4) · Agree	26 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with growth of hair (At Week 4) · Disagree	12 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with growth of hair (At Week 4) · Neutral	18 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with growth of hair (At Week 6) · Agree	40 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with growth of hair (At Week 6) · Disagree	5 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with growth of hair (At Week 6) · Neutral	11 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with growth of hair (At Week 12) · Agree	44 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with growth of hair (At Week 12) · Disagree	7 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with growth of hair (At Week 12) · Neutral	5 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hairline at the front of the head (At Week 4) · Agree	21 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hairline at the front of the head (At Week 4) · Disagree	16 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hairline at the front of the head (At Week 4) · Neutral	19 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hairline at the front of the head (At Week 6) · Agree	26 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hairline at the front of the head (At Week 6) · Disagree	10 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hairline at the front of the head (At Week 6) · Neutral	20 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hairline at the front of the head (At Week 12) · Agree	34 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hairline at the front of the head (At Week 12) · Disagree	8 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hairline at the front of the head (At Week 12) · Neutral	14 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair on the top of the head (At Week 4) · Agree	21 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair on the top of the head (At Week 4) · Disagree	16 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair on the top of the head (At Week 4) · Neutral	19 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair on the top of the head (At Week 6) · Agree	36 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair on the top of the head (At Week 6) · Disagree	7 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair on the top of the head (At Week 6) · Neutral	13 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair on the top of the head (At Week 12) · Agree	37 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair on the top of the head (At Week 12) · Disagree	7 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair on the top of the head (At Week 12) · Neutral	12 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair overall as an overall improvement from the baseline (At Week 4) · Agree	21 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair overall as an overall improvement from the baseline (At Week 4) · Disagree	13 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair overall as an overall improvement from the baseline (At Week 4) · Neutral	22 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair overall as an overall improvement from the baseline (At Week 6) · Agree	34 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair overall as an overall improvement from the baseline (At Week 6) · Disagree	5 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair overall as an overall improvement from the baseline (At Week 6) · Neutral	17 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair overall as an overall improvement from the baseline (At Week 12) · Agree	39 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair overall as an overall improvement from the baseline (At Week 12) · Disagree	6 Participants
Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire Satisfaction with hair overall as an overall improvement from the baseline (At Week 12) · Neutral	11 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From start of study up to Week 12

Population: SP included all participants who were enrolled and received at least one dose of study product.

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.

Outcome measures

Outcome measures
Measure	Minoxidil 5% Foam and Botanical Hair Solution for Men n=61 Participants Participant were applied with minoxidil 5% foam on the scalp in the hair loss and botanical hair solution (5-10 sprays) for men on entire scalp (wet or dry) twice per day for 12 weeks.
Number of Participants With Adverse Events (AEs)	4 Participants

Adverse Events

Minoxidil 5% Foam and Botanical Hair Solution for Men

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Minoxidil 5% Foam and Botanical Hair Solution for Men n=61 participants at risk Participant were applied with minoxidil 5% foam on the scalp in the hair loss and botanical hair solution (5-10 sprays) for men on entire scalp (wet or dry) twice per day for 12 weeks.
General disorders Pain (crown of head)	1.6% 1/61 • From Start of Study up to Week 12 The safety population was defined as all participants who were enrolled and received at least one dose of study product.
Respiratory, thoracic and mediastinal disorders Bronchitis	1.6% 1/61 • From Start of Study up to Week 12 The safety population was defined as all participants who were enrolled and received at least one dose of study product.
Musculoskeletal and connective tissue disorders Joint Injury	1.6% 1/61 • From Start of Study up to Week 12 The safety population was defined as all participants who were enrolled and received at least one dose of study product.
Ear and labyrinth disorders Middle ear effusion	1.6% 1/61 • From Start of Study up to Week 12 The safety population was defined as all participants who were enrolled and received at least one dose of study product.

Additional Information

Clinical Operations

Galderma

Phone: 817 961 5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place