Male Pattern of Hair Loss, Androgenic Alopecia
Conditions
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).
Interventions
DRUGTreatment: Minoxidil 5% / Botanical Hair Solution for Men
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Investigator's Rating of Standardized Global Photographs at Week 12 | 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. |
| Change From Baseline in Participant Rating at Week 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Shed Hair Count | At Week 12 | 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. |
| Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | At Week 4,6 and 12 | 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | From start of study up to Week 12 | 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. |
Countries
United States
Participant flow
Recruitment details
The study was conducted in the United States from 19 May 2015 to 19 September 2015.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 61 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 8 |
Baseline characteristics
| Characteristic | Minoxidil 5% Foam and Botanical Hair Solution for Men |
|---|---|
| Age, Continuous | 45.1 years STANDARD_DEVIATION 9.7 |
| Fitzpatrick Skin Type II | 6 Participants |
| Fitzpatrick Skin Type III | 32 Participants |
| Fitzpatrick Skin Type IV | 18 Participants |
| Fitzpatrick Skin Type V | 5 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants |
| Race/Ethnicity, Customized Asian | 4 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 11 Participants |
| Race/Ethnicity, Customized White | 37 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 61 |
| other Total, other adverse events | 4 / 61 |
| serious Total, serious adverse events | 0 / 61 |
Outcome results
Primary
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.
Time frame: At Week 12
Population: ITT population included all participants who were randomized and have at least one post-treatment administration evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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
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.
Time frame: At Week 12
Population: lIT population included all participants who were randomized and had at least one post-treatment administration evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Change From Baseline in Participant Rating at Week 12 | Appearance of hair | 5.4 Score on a scale | Standard Deviation 1.2 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Change From Baseline in Participant Rating at Week 12 | Growth of hair | 5.3 Score on a scale | Standard Deviation 1.3 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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
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.
Time frame: At Week 12
Population: lTT population included all participants who were randomized and had at least one post-treatment administration evaluation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Mean Change From Baseline in Shed Hair Count | 14.1 Shed Hair Count | Standard Deviation 21.6 |
Secondary
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).
Time frame: At Week 4,6 and 12
Population: lTT population included all participants who were randomized and had at least one post-treatment administration evaluation.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with appearance of hair (At Week 4) | Agree | 27 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with appearance of hair (At Week 4) | Disagree | 8 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with appearance of hair (At Week 4) | Neutral | 21 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with appearance of hair (At Week 6) | Agree | 42 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with appearance of hair (At Week 6) | Disagree | 4 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with appearance of hair (At Week 6) | Neutral | 10 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with appearance of hair (At Week 12) | Agree | 44 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with appearance of hair (At Week 12) | Disagree | 4 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with appearance of hair (At Week 12) | Neutral | 8 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with growth of hair (At Week 4) | Agree | 26 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with growth of hair (At Week 4) | Disagree | 12 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with growth of hair (At Week 4) | Neutral | 18 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with growth of hair (At Week 6) | Agree | 40 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with growth of hair (At Week 6) | Disagree | 5 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with growth of hair (At Week 6) | Neutral | 11 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with growth of hair (At Week 12) | Agree | 44 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with growth of hair (At Week 12) | Disagree | 7 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participant in Each Response Category Based on Subject Satisfaction Questionnaire | Satisfaction with growth of hair (At Week 12) | Neutral | 5 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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 |
| Minoxidil 5% Foam and Botanical Hair Solution for Men | 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
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Minoxidil 5% Foam and Botanical Hair Solution for Men | Number of Participants With Adverse Events (AEs) | 4 Participants |