Female Pattern Hair Loss, Androgenic AlopeciaNCT02460497
Minoxidil 2% Solution and Botanical Hair Regimen in Women With Thinning Hair and Female Pattern Hair Loss/Androgenic Alopecia
A study testing Treatment: Minoxidil 2% / Botanical Hair Solution for Women in people with Female Pattern Hair Loss, Androgenic Alopecia, run by Galderma R&D at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Female Pattern Hair Loss, Androgenic Alopecia
- What is being tested?
- Treatment: Minoxidil 2% / Botanical Hair Solution for Women
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 27 May 2015to 19 Sep 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
- Being tested
- Treatment: Minoxidil 2% / Botanical Hair Solution for Women
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment: Minoxidil 2% / Botanical Hair Solution for WomenDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Treatment: Minoxidil 2% / Botanical Hair Solution for Women |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 12
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From start of study drug administration up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study start27 May 2015
- Primary completion19 Sep 2015
- Study completion19 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Female Pattern Hair Loss, Androgenic AlopeciaStudies of the same condition, open and under way.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460497
- Sponsor's protocol ID
- GLI.04.SPR.US10330
- Status last verified
- Jul 2023
- First submitted
- 29 May 2015
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02460497
- Acronym / sponsor ID
- GLI.04.SPR.US10330
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 27 May 2015 (actual)
- Primary completion
- 19 Sep 2015 (actual)
- Study completion
- 19 Sep 2015 (actual)
- First posted
- 2 Jun 2015 (estimated)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Treatment: Minoxidil 2% / Botanical Hair Solution for Women |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment: Minoxidil 2% / Botanical Hair Solution for Women | Drug | Treatment |
Primary outcome
Change From Baseline in Investigator's Rating of Global Photographs at Week 12
Time frame: 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.
4 secondary outcomes
Change From Baseline in Participant Rating at Week 12
Time frame: At Week 12
Mean Change From Baseline in Shed Hair Count
Time frame: At Week 12
Number of Participants in Each Response Category Based on Subject Satisfaction Questionnaire
Time frame: At Week 4, 6 and 12
Number of Participants With Adverse Events (AEs)
Time frame: From start of study drug administration up to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment: Minoxidil 2% / Botanical Hair Solution for Women in people with Female Pattern Hair Loss, Androgenic Alopecia, run by Galderma R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Investigator's Rating of Global Photographs at Week 12 (time frame: At Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.