Female Pattern Hair Loss, Androgenic Alopecia
Conditions
Brief summary
The purpose of this study is to characterize the effect of Minoxidil 2% Solution and Botanical Hair Solution Regimen in women with thinning hair and female pattern hair loss/androgenic alopecia (Ludwig I and II).
Interventions
DRUGTreatment: Minoxidil 2% / Botanical Hair Solution for Women
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Female patients age 18 to 60 years at the time of enrollment. 2. Women who have self-perceived thinning hair. 3. Women who have presentation of female pattern hair loss/androgenic alopecia (Ludwig I and II). 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. 5\. Subjects who have recently (within the last 6 months) started the use of hormones for birth control or hormone replacement therapy (HRT). Women currently using hormones for birth control or HRT must have been on a stable dose (6 months or longer) in order to be eligible for the study. 6\. Pregnant or breast-feeding females or women planning to become pregnant during the course of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Investigator's Rating of 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. The score on the 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 |
|---|---|---|
| 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. The scores on the 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. |
| 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 Participants in Each Response Category Based on Subject Satisfaction Questionnaire | At Week 4, 6 and 12 | Participant satisfaction with the treatment experience data was collected via a written questionnaire This questionnaire composed of 5-point Likert scale questions, as well as free-text responses. Participants were asked to determine overall satisfaction with the treatment. The choices were: 1-2 = Agree; 4-5 = Disagree; 3 = Neutral. |
| Number of Participants With Adverse Events (AEs) | From start of study drug administration 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 at 1 center in the United States from 27 May 2015 to 19 September 2015.
Pre-assignment details
A total of 61 participants were enrolled and received treatment in this study.
Participants by arm
| Arm | Count |
|---|---|
| Minoxidil 5% Foam and Botanical Hair Solution Participant received minoxidil 2% solution 1 mL on the scalp in the hair loss area and botanical hair solution (5-10 sprays) for women on entire scalp twice per day for up to 12 weeks. | 60 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not Meet Protocol Criteria | 1 |
| Overall Study | Investigator Decision | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Non-Compliance | 1 |
| Overall Study | Participant Requested Withdrawal | 4 |
Baseline characteristics
| Characteristic | Minoxidil 5% Foam and Botanical Hair Solution |
|---|---|
| Age, Continuous | 46.9 years STANDARD_DEVIATION 10.6 |
| Fitzpatrick Skin Type II | 15 Participants |
| Fitzpatrick Skin Type III | 17 Participants |
| Fitzpatrick Skin Type IV | 21 Participants |
| Fitzpatrick Skin Type V | 7 Participants |
| Race/Ethnicity, Customized Race Asian | 5 Participants |
| Race/Ethnicity, Customized Race Black or African American | 12 Participants |
| Race/Ethnicity, Customized Race Hispanic or Latino | 11 Participants |
| Race/Ethnicity, Customized Race Multi-Racial | 1 Participants |
| Race/Ethnicity, Customized Race White | 31 Participants |
| Sex: Female, Male Female | 60 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 60 |
| other Total, other adverse events | 4 / 60 |
| serious Total, serious adverse events | 0 / 60 |
Outcome results
Primary
Change From Baseline in Investigator's Rating of 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. The score on the 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 | Change From Baseline in Investigator's Rating of Global Photographs at Week 12 | Overall perception of treatment benefit | 5.0 Score on a scale | Standard Deviation 0.9 |
| Minoxidil 5% Foam and Botanical Hair Solution | Change From Baseline in Investigator's Rating of Global Photographs at Week 12 | Hair Thinning | 4.9 Score on a scale | Standard Deviation 0.9 |
| Minoxidil 5% Foam and Botanical Hair Solution | Change From Baseline in Investigator's Rating of Global Photographs at Week 12 | Hair Growth | 4.9 Score on a scale | Standard Deviation 0.8 |
| Minoxidil 5% Foam and Botanical Hair Solution | Change From Baseline in Investigator's Rating of Global Photographs at Week 12 | Impression of scalp hair coverage | 4.8 Score on a scale | Standard Deviation 0.8 |
Secondary
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. The scores on the 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 had at least one post-treatment administration evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Minoxidil 5% Foam and Botanical Hair Solution | Change From Baseline in Participant Rating at Week 12 | Growth of hair | 5.4 Score on a scale | Standard Deviation 1.5 |
| Minoxidil 5% Foam and Botanical Hair Solution | Change From Baseline in Participant Rating at Week 12 | Satisfaction with hair on the top of the head | 5.1 Score on a scale | Standard Deviation 1.5 |
| Minoxidil 5% Foam and Botanical Hair Solution | Change From Baseline in Participant Rating at Week 12 | Appearance of hair | 5.6 Score on a scale | Standard Deviation 1.3 |
| Minoxidil 5% Foam and Botanical Hair Solution | Change From Baseline in Participant Rating at Week 12 | Satisfaction with hairline at the front of the head | 5.1 Score on a scale | Standard Deviation 1.5 |
| Minoxidil 5% Foam and Botanical Hair Solution | Change From Baseline in Participant Rating at Week 12 | Satisfaction with hair overall as an overall improvement from the baseline | 5.5 Score on a scale | Standard Deviation 1.5 |
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: The ITT 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 | Mean Change From Baseline in Shed Hair Count | 4.9 Shed Hair Count | Standard Deviation 121.8 |
Secondary
Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire
Participant satisfaction with the treatment experience data was collected via a written questionnaire This questionnaire composed of 5-point Likert scale questions, as well as free-text responses. Participants were asked to determine overall satisfaction with the treatment. The choices were: 1-2 = Agree; 4-5 = Disagree; 3 = Neutral.
Time frame: At Week 4, 6 and 12
Population: The ITT 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 | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I received compliments from friends and family members about my hair (At Week 12) | Neutral | 13 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I would purchase this Regimen (At Week 12) | Agree | 40 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in the appearance of my hair (At Week 4) | Agree | 27 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in the appearance of my hair (At Week 4) | Disagree | 13 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in the appearance of my hair (At Week 4) | Neutral | 14 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in the appearance of my hair (At Week 6) | Agree | 37 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in the appearance of my hair (At Week 6) | Disagree | 9 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in the appearance of my hair (At Week 6) | Neutral | 8 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in the appearance of my hair (At Week 12) | Agree | 45 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in the appearance of my hair (At Week 12) | Disagree | 4 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in the appearance of my hair (At Week 12) | Neutral | 5 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen provides thicker looking hair (At Week 4) | Agree | 25 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen provides thicker looking hair (At Week 4) | Disagree | 15 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen provides thicker looking hair (At Week 4) | Neutral | 14 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen provides thicker looking hair (At Week 6) | Agree | 38 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen provides thicker looking hair (At Week 6) | Disagree | 10 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen provides thicker looking hair (At Week 6) | Neutral | 6 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks fuller (At Week 4) | Agree | 25 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks fuller (At Week 4) | Disagree | 16 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks fuller (At Week 4) | Neutral | 13 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks fuller (At Week 6) | Agree | 35 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks fuller (At Week 6) | Disagree | 9 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks fuller (At Week 6) | Neutral | 10 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks noticeably fuller (At Week 12) | Agree | 38 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks noticeably fuller (At Week 12) | Disagree | 8 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks noticeably fuller (At Week 12) | Neutral | 6 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen provides healthier looking hair (At Week 4) | Agree | 26 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen provides healthier looking hair (At Week 4) | Disagree | 12 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen provides healthier looking hair (At Week 4) | Neutral | 16 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen provides healthier looking hair (At Week 6) | Agree | 31 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen provides healthier looking hair (At Week 6) | Disagree | 8 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen provides healthier looking hair (At Week 6) | Neutral | 15 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I am happy with the appearance of hair (At Week 4) | Agree | 24 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I am happy with the appearance of hair (At Week 4) | Disagree | 17 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I am happy with the appearance of hair (At Week 4) | Neutral | 13 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I am happy with the appearance of hair (At Week 6) | Agree | 31 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I am happy with the appearance of hair (At Week 6) | Disagree | 12 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I am happy with the appearance of hair (At Week 6) | Neutral | 11 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair volume (At Week 4) | Agree | 24 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair volume (At Week 4) | Disagree | 18 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair volume (At Week 4) | Neutral | 12 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair volume (At Week 6) | Agree | 35 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair volume (At Week 6) | Disagree | 8 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair volume (At Week 6) | Neutral | 11 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair volume (At Week 12) | Agree | 43 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair volume (At Week 12) | Disagree | 5 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair volume (At Week 12) | Neutral | 6 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair texture (At Week 4) | Agree | 22 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair texture (At Week 4) | Disagree | 17 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair texture (At Week 4) | Neutral | 15 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair texture (At Week 6) | Agree | 28 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair texture (At Week 6) | Disagree | 10 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair texture (At Week 6) | Neutral | 16 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair texture (At Week 12) | Agree | 36 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair texture (At Week 12) | Disagree | 10 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | This Regimen improves my hair texture (At Week 12) | Neutral | 8 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in my hair quality (At Week 4) | Agree | 26 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in my hair quality (At Week 4) | Disagree | 12 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in my hair quality (At Week 4) | Neutral | 16 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in my hair quality (At Week 6) | Agree | 35 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in my hair quality (At Week 6) | Disagree | 6 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in my hair quality (At Week 6) | Neutral | 13 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in my hair quality (At Week 12) | Agree | 41 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in my hair quality (At Week 12) | Disagree | 7 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I have noticed an improvement in my hair quality (At Week 12) | Neutral | 6 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My scalp feels better since beginning this Regimen (At Week 4) | Agree | 24 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My scalp feels better since beginning this Regimen (At Week 4) | Disagree | 13 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My scalp feels better since beginning this Regimen (At Week 4) | Neutral | 17 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My scalp feels better since beginning this Regimen (At Week 6) | Agree | 27 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My scalp feels better since beginning this Regimen (At Week 6) | Disagree | 6 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My scalp feels better since beginning this Regimen (At Week 6) | Neutral | 21 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks stronger (At Week 4) | Agree | 29 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks stronger (At Week 4) | Disagree | 10 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks stronger (At Week 4) | Neutral | 15 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks stronger (At Week 6) | Agree | 35 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks stronger (At Week 6) | Disagree | 8 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks stronger (At Week 6) | Neutral | 11 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks stronger (At Week 12) | Agree | 43 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks stronger (At Week 12) | Disagree | 6 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks stronger (At Week 12) | Neutral | 5 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I like the Regimen I used in this study (At Week 12) | Agree | 43 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I like the Regimen I used in this study (At Week 12) | Disagree | 5 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I like the Regimen I used in this study (At Week 12) | Neutral | 4 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I received compliments from friends and family members about my hair (At Week 12) | Agree | 23 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I received compliments from friends and family members about my hair (At Week 12) | Disagree | 16 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I would recommend this Regimen to others (At Week 12) | Agree | 42 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I would recommend this Regimen to others (At Week 12) | Disagree | 6 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I would recommend this Regimen to others (At Week 12) | Neutral | 4 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I feel younger (At Week 12) | Agree | 23 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I feel younger (At Week 12) | Disagree | 10 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I feel younger (At Week 12) | Neutral | 19 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I thought this Regimen did better than my previous hair thinning products (At Week 12) | Agree | 23 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I thought this Regimen did better than my previous hair thinning products (At Week 12) | Disagree | 8 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I thought this Regimen did better than my previous hair thinning products (At Week 12) | Neutral | 21 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I feel more attractive (At Week 12) | Agree | 33 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I feel more attractive (At Week 12) | Disagree | 11 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I feel more attractive (At Week 12) | Neutral | 8 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I feel more sociable (At Week 12) | Agree | 26 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I feel more sociable (At Week 12) | Disagree | 11 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I feel more sociable (At Week 12) | Neutral | 15 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I feel more confident (At Week 12) | Agree | 31 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I feel more confident (At Week 12) | Disagree | 9 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I feel more confident (At Week 12) | Neutral | 12 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I would purchase this Regimen (At Week 12) | Disagree | 6 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | I would purchase this Regimen (At Week 12) | Neutral | 6 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks heathier (At Week 12) | Agree | 43 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks heathier (At Week 12) | Disagree | 5 Participants |
| Minoxidil 5% Foam and Botanical Hair Solution | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | My hair looks heathier (At Week 12) | Neutral | 4 Participants |
Secondary
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 drug administration 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 | Number of Participants With Adverse Events (AEs) | 2 Participants |