Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment: Minoxidil 2% / Botanical Hair Solution for Women | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephens & Associates | Richardson | Texas | 75081 | United States |
A total of 61 participants were enrolled and received treatment in this study.
The study was conducted at 1 center in the United States from 27 May 2015 to 19 September 2015.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Minoxidil 5% Foam and Botanical Hair Solution | Participant received minoxidil 2% solution 1 milliliter (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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| At Week 12 |
| 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 |
| 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. | At Week 4, 6 and 12 |
| 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 drug administration up to Week 12 |
| Intent-to-treat (ITT) Population |
|
| Safety Population (SP) |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
SP included all participants who were enrolled and received at least one dose of study product.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Fitzpatrick Skin Type | Fitzpatrick skin type is a numerical classification scale for the color of skin from Type 1 to Type VI. I - Always bums; never tans II - Bums easily; tans minimally III - Burns moderately; tans gradually to light brown IV - Burns minimally; tans well to moderate brown V - Rarely burns; tans profusely to dark brown VI - Never bums; tans profusely to black. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | ITT population included all participants who were randomized and have at least one post-treatment administration evaluation. | Posted | Mean | Standard Deviation | Score on a scale | At Week 12 |
|
|
| |||||||||||||||||||||||||||||||||||
| 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. | ITT population included all participants who were randomized and had at least one post-treatment administration evaluation. | Posted | Mean | Standard Deviation | Score on a scale | 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. | The ITT population included all participants who were randomized and had at least one post-treatment administration evaluation. | Posted | Mean | Standard Deviation | Shed Hair Count | At Week 12 |
|
| ||||||||||||||||||||||||||||||||||||
| 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. | The ITT population included all participants who were randomized and had at least one post-treatment administration evaluation. | Posted | Count of Participants | Participants | At Week 4, 6 and 12 |
|
| |||||||||||||||||||||||||||||||||||||
| 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. | SP included all participants who were enrolled and received at least one dose of study product. | Posted | Count of Participants | Participants | From start of study drug administration up to Week 12 |
|
From start of study drug administration up to Week 12
SP included all participants who were enrolled and received at least one dose of study product.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 60 | 0 | 60 | 4 | 60 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Influenza | Gastrointestinal disorders | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Hispanic or Latino |
|
| White |
|
| Multi-Racial |
|
| IV |
|
| V |
|
| Title | Measurements |
|---|---|
|
| Overall perception of treatment benefit |
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|