Trial · NCT02460497
Minoxidil 2% Solution and Botanical Hair Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia
NCT02460497, Not applicable, Completed, Galderma R&D; results first posted 2023-08-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Minoxidil 2% Solution and Botanical Hair Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia. Trials, record NCT02460497. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02460497
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Minoxidil 2% Solution and Botanical Hair Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia
- NCT number
- NCT02460497
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 61 participants, actual
- Lead sponsor
- Galderma R&D
- Conditions
- Female Pattern Hair Loss, Androgenic Alopecia
- Interventions
- Treatment: Minoxidil 2% / Botanical Hair Solution for Women
- First posted
- 2015-06-02
- Last updated
- 2023-08-01
- Results first posted
- 2023-08-01
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Investigator's Rating of Global Photographs at Week 12 | 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 | Change From Baseline in Participant Rating at Week 12 | 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. |
| Secondary | Mean Change From Baseline in Shed Hair Count | At Week 12 | 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. |
| Secondary | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | At Week 4, 6 and 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. |
| Secondary | Number of Participants With Adverse Events (AEs) | From start of study drug administration up to Week 12 | 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. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Investigator's Rating of Global Photographs at Week 12 | At Week 12 | ITT population included all participants who were randomized and have at least one post-treatment administration evaluation. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Participant Rating at Week 12 | At Week 12 | ITT population included all participants who were randomized and had at least one post-treatment administration evaluation. | Score on a scale | MEAN |
| SECONDARY | Mean Change From Baseline in Shed Hair Count | At Week 12 | The ITT population included all participants who were randomized and had at least one post-treatment administration evaluation. | Shed Hair Count | MEAN |
| SECONDARY | Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire | At Week 4, 6 and 12 | The ITT population included all participants who were randomized and had at least one post-treatment administration evaluation. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Adverse Events (AEs) | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group119
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Investigator's Rating of Global Photographs at Week 12 | Minoxidil 5% Foam and Botanical Hair Solution | Hair Thinning | 4.9 | Standard Deviation 0.9 | Score on a scale |
| Change From Baseline in Investigator's Rating of Global Photographs at Week 12 | Minoxidil 5% Foam and Botanical Hair Solution | Hair Growth | 4.9 | Standard Deviation 0.8 | Score on a scale |
| Change From Baseline in Investigator's Rating of Global Photographs at Week 12 | Minoxidil 5% Foam and Botanical Hair Solution | Impression of scalp hair coverage | 4.8 | Standard Deviation 0.8 | Score on a scale |
| Change From Baseline in Investigator's Rating of Global Photographs at Week 12 | Minoxidil 5% Foam and Botanical Hair Solution | Overall perception of treatment benefit | 5.0 | Standard Deviation 0.9 | Score on a scale |
| Change From Baseline in Participant Rating at Week 12 | Minoxidil 5% Foam and Botanical Hair Solution | Appearance of hair | 5.6 | Standard Deviation 1.3 | Score on a scale |
| Change From Baseline in Participant Rating at Week 12 | Minoxidil 5% Foam and Botanical Hair Solution | Growth of hair | 5.4 | Standard Deviation 1.5 | Score on a scale |
| Change From Baseline in Participant Rating at Week 12 | Minoxidil 5% Foam and Botanical Hair Solution | Satisfaction with hairline at the front of the head | 5.1 | Standard Deviation 1.5 | Score on a scale |
| Change From Baseline in Participant Rating at Week 12 | Minoxidil 5% Foam and Botanical Hair Solution | Satisfaction with hair on the top of the head | 5.1 | Standard Deviation 1.5 | Score on a scale |
| Change From Baseline in Participant Rating at Week 12 | Minoxidil 5% Foam and Botanical Hair Solution | Satisfaction with hair overall as an overall improvement from the baseline | 5.5 | Standard Deviation 1.5 | Score on a scale |
| Mean Change From Baseline in Shed Hair Count | Minoxidil 5% Foam and Botanical Hair Solution | 4.9 | Standard Deviation 121.8 | Shed Hair Count |
1 to 10 of 119Source ClinicalTrials.gov
See all 119 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Minoxidil 5% Foam and Botanical Hair Solution | 61 | |
| Overall Study | Intent-to-treat (ITT) Population | Minoxidil 5% Foam and Botanical Hair Solution | 54 | |
| Overall Study | Safety Population (SP) | Minoxidil 5% Foam and Botanical Hair Solution | 60 | |
| Overall Study | COMPLETED | Minoxidil 5% Foam and Botanical Hair Solution | 52 | |
| Overall Study | NOT COMPLETED | Minoxidil 5% Foam and Botanical Hair Solution | 9 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Back Pain | Musculoskeletal and connective tissue disorders | Minoxidil 5% Foam and Botanical Hair Solution | 1 | 60 | |
| other | Abdominal pain | Gastrointestinal disorders | Minoxidil 5% Foam and Botanical Hair Solution | 1 | 60 | |
| other | Nausea | Gastrointestinal disorders | Minoxidil 5% Foam and Botanical Hair Solution | 1 | 60 | |
| other | Influenza | Gastrointestinal disorders | Minoxidil 5% Foam and Botanical Hair Solution | 1 | 60 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Minoxidil 5% Foam and Botanical Hair Solution | 0 | 60 |
| Total, other adverse events | Minoxidil 5% Foam and Botanical Hair Solution | 4 | 60 |
| Total, serious adverse events | Minoxidil 5% Foam and Botanical Hair Solution | 0 | 60 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02460497
GET https://conductscience.org/api/trials/v1/NCT02460497/results?page=2