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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment: Minoxidil 5% / Botanical Hair Solution for Men | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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.
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| Name | Affiliation | Role |
|---|---|---|
| Warren Winkelman, MD, PhD, MBA | Galderma R&D | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephens & Associates | Richardson | Texas | 75081 | United States |
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The study was conducted in the United States from 19 May 2015 to 19 September 2015.
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| ID | Title | Description |
|---|---|---|
| FG000 | Minoxidil 5% Foam and Botanical Hair Solution for Men | Participant were applied with minoxidil 5% foam on the scalp in the hair loss and botanical hair solution (5-10 sprays) for men on entire scalp (wet or dry) twice per day for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
SP included all participants who were enrolled and received at least one dose of study product.
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| ID | Title | Description |
|---|---|---|
| BG000 | Minoxidil 5% Foam and Botanical Hair Solution for Men | Participant were applied with minoxidil 5% foam on the scalp in the hair loss and botanical hair solution (5-10 sprays) for men on entire scalp (wet or dry) twice per day for 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 |
| 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 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. | 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 |
|
From Start of Study up to Week 12
The safety population was defined as all participants who were enrolled and received at least one dose of study product.
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| 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 for Men | Participant were applied with minoxidil 5% foam on the scalp in the hair loss and botanical hair solution (5-10 sprays) for men on entire scalp (wet or dry) twice per day for 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain (crown of head) | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Operations | Galderma | 817 961 5000 | 1 | Clinical.Studies@galderma.com |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017290 | Menogaril |
| ID | Term |
|---|---|
| D009621 | Nogalamycin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
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| 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 |
| From start of study up to Week 12 |
| 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 |
|
Participant were applied with minoxidil 5% foam on the scalp in the hair loss and botanical hair solution (5-10 sprays) for men on entire scalp (wet or dry) twice per day for 12 weeks. |
|
|
| 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. | lIT 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. | lTT 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 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). | lTT 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 |
|
|
|
| Other Pre-specified | 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 up to Week 12 |
|
|
|
| 0 |
| 61 |
| 0 |
| 61 |
| 4 |
| 61 |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Joint Injury | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Middle ear effusion | Ear and labyrinth disorders | Systematic Assessment |
|
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| Title | Measurements |
|---|---|
|
| Satisfaction with hair on the top of the head |
|
| Satisfaction with hair overall as an overall improvement |
|
| Satisfaction with appearance of hair (At Week 6) |
|
| Satisfaction with appearance of hair (At Week 12) |
|
| Satisfaction with growth of hair (At Week 4) |
|
| Satisfaction with growth of hair (At Week 6) |
|
| Satisfaction with growth of hair (At Week 12) |
|
| Satisfaction with hairline at the front of the head (At Week 4) |
|
| Satisfaction with hairline at the front of the head (At Week 6) |
|
| Satisfaction with hairline at the front of the head (At Week 12) |
|
| Satisfaction with hair on the top of the head (At Week 4) |
|
| Satisfaction with hair on the top of the head (At Week 6) |
|
| Satisfaction with hair on the top of the head (At Week 12) |
|
| Satisfaction with hair overall as an overall improvement from the baseline (At Week 4) |
|
| Satisfaction with hair overall as an overall improvement from the baseline (At Week 6) |
|
| Satisfaction with hair overall as an overall improvement from the baseline (At Week 12) |
|