Back to resultsMinoxidil 2% Solution and Botanical Hair Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia
Primary Purpose
Female Pattern Hair Loss, Androgenic Alopecia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treatment: Minoxidil 2% / Botanical Hair Solution for Women
Sponsored by
About this trial
This is an interventional treatment trial for Female Pattern Hair Loss, Androgenic Alopecia
Eligibility Criteria
Key Inclusion Criteria:
- Female patients age 18 to 60 years at the time of enrollment.
- Women who have self-perceived thinning hair.
- Women who have presentation of female pattern hair loss/androgenic alopecia (Ludwig I and II).
Key Exclusion Criteria:
- History of allergic reactions or severe intolerance to minoxidil and Botanical Hair Solution product ingredients.
- 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
Sites / Locations
- Stephens & Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02460497
Brief Title
Minoxidil 2% Solution and Botanical Hair Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia
Official Title
Multicenter, Open Label Clinical Trial to Evaluate the Effect and Tolerability 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)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 27, 2015 (Actual)
Primary Completion Date
September 19, 2015 (Actual)
Study Completion Date
September 19, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Female Pattern Hair Loss, Androgenic Alopecia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Treatment: Minoxidil 2% / Botanical Hair Solution for Women
Primary Outcome Measure Information:
Title
Change From Baseline in Investigator's Rating of Global Photographs at Week 12
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline in Participant Rating at Week 12
Description
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
Title
Mean Change From Baseline in Shed Hair Count
Description
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
Title
Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire
Description
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
Title
Number of Participants With Adverse Events (AEs)
Description
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Female patients age 18 to 60 years at the time of enrollment.
Women who have self-perceived thinning hair.
Women who have presentation of female pattern hair loss/androgenic alopecia (Ludwig I and II).
Key Exclusion Criteria:
History of allergic reactions or severe intolerance to minoxidil and Botanical Hair Solution product ingredients.
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
Facility Information:
Facility Name
Stephens & Associates
City
Richardson
State/Province
Texas
ZIP/Postal Code
75081
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Minoxidil 2% Solution and Botanical Hair Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia
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