Male Pattern of Hair Loss, Androgenic Alopecia Clinical Trial
Official title:
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)
| Verified date | July 2023 |
| Source | Galderma R&D |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 63 |
| Est. completion date | November 2015 |
| Est. primary completion date | November 2015 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 18 Years to 60 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Stephens & Associates | Richardson | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Galderma R&D |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | 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 | |
| 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. | At Week 12 | |
| 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. | At Week 12 | |
| 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. | At Week 12 | |
| 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). | At Week 4,6 and 12 |