Trial Outcomes & Findings for Minoxidil 2% Solution and Botanical Hair Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia (NCT NCT02460497)

The study was conducted at 1 center in the United States from 27 May 2015 to 19 September 2015.

A total of 61 participants were enrolled and received treatment in this study.

Minoxidil 2% Solution and Botanical Hair Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia

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.

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.

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.

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.

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.