Androgenetic AlopeciaPhase 3NCT00958750
Efficacy and Safety Study to Compare Two Minoxidil Formulations on Women With Androgenetic Alopecia
A Phase 3 study testing minoxidil in people with Androgenetic Alopecia and Female Pattern Hair Loss, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to determine in women the risk/benefit profile and non-inferiority of a topical 5% Minoxidil foam formulation applied once daily for the treatment of androgenetic alopecia in comparison to 2% MTS used twice daily, using objective and subjective efficacy measures and safety assessments for… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Androgenetic Alopecia, Female Pattern Hair Loss
- What is being tested?
- minoxidil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Jun 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, age 18 or older, in general good health
- Exhibits AGA based on a discernable decrease in hair density on the top of the scalp, relative to the sides and back of the scalp, with scalp hair density in involved area D3 to D6 on the Savin Density Scale (See Appendix 1)
- Hair density equal or less than 220 hairs /cm2 measured with TrichoScan
- Subjects who give their consent to the study after thoroughly clarification and who personally signed and dated the informed consent document indicating that the subject (or a legally acceptable representative), has been informed of all pertinent aspects of the trial
- Women of childbearing potential, who practice an effective method of contraception for at least five consecutive weeks prior to the study entry and during the study with one of the following methods:
- Double contraceptive method among hormonal contraception (e.g. contraceptive pill, intra uterine device, vaginal ring, injectable or implantable contraception), spermicide, condom and diaphragm. Oral/systemic contraception must have been the same during the past 6 months and will not be changed during the study
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- Sexual abstinence
- Partner with a vasectomy (dated back more than 6 months) OR
- Women of non-childbearing potential, i. e. postmenopausal (absence of menstrual bleeding for 2 years), or had hysterectomy, bilateral tubal ligation or bilateral ovariectomy
- Women of childbearing potential must show a negative urine pregnancy test at Screening
- Willing to maintain the same hairstyle, hair length and hair color throughout the study
- Subjects who are willing and able to comply with scheduled visits, treatment plan, mini-tattoo, laboratory test and other trial procedures.
Who cannot join
- Known to be hypersensitive to Minoxidil, hair dye (P-Phenylendiamin), Tattoo ink, propylene glycol, fragrances, hair gel or any vehicle components.
- Current or 4 weeks dated back use of local treatment (drug or cosmetically) in the target region interfering with the study product or examination method (corticosteroids, Aminexil, Minoxidil, medical shampoos, topical estrogen, Ketoconazol)
- Current or 3 months dated back use of systemic treatment (drugs or dietary supplement) taken for more than 2 consecutive weeks interfering with the study product or examination method (beta blocker, Cimetidine, Diazoxid, Isotretinoin, corticosteroids, vitamin A intake above 10000 IU per day)
- Within past 6 month receiving of chemotherapy/cytotoxic agents as well as radiation and/or laser/surgical therapy of the scalp
- Current or prior enrollment in any other investigational medication (drug) study within the last 4 weeks
- Women with childbearing potential and insufficient contraception.
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- Female who is pregnant, planning a pregnancy (during the course of the study) or nursing a child
- Presence of hair transplants, hair weaves or non-breathable wigs
- Any dermatological disorders of the scalp in the target region with the possibility of interfering with the study product or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars or scalp atrophy
- Active hair loss or history within the past 3 months including diffuse telogen effluvium, alopecia areata, scarring alopecia and androgen hair loss /hyper-androgenemia)
- Other severe, acute or chronic medical condition that may lead to hair loss or interfere with the interpretation of trial results
- Individuals who are institutionalized by court or regulatory order
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité-Universitaetsmedizin; Clinical Research Center for Hair and Skin Science
Berlin, 10117
About this study
Official title: Investigator-initiated Single Blind, Two-armed, Randomized Phase 3 Clinical Trial to Compare Efficacy of 5% Minoxidil Topical Foam (5% Mtf) Once Daily Versus 2% Minoxidil Topical Solution (2% Mts) Twice Daily in Application on Females With Slightly to Moderate Androgenetic Alopecia Concerning Hair Volume
The purpose of this study is to determine in women the risk/benefit profile and non-inferiority of a topical 5% Minoxidil foam formulation applied once daily for the treatment of androgenetic alopecia in comparison to 2% MTS used twice daily, using objective and subjective efficacy measures and safety assessments for a study period of 24 weeks.
- Conditions
- Androgenetic Alopecia, Female Pattern Hair Loss
- Being tested
- minoxidil
- Keywords
- Androgenetic alopecia, female pattern hair loss
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minoxidilDrug
the investigators compared two different formulations and concentrations of minoxidil in this study
| Study group | Role | What they receive |
|---|---|---|
| 5% MTF | Active comparator | 5% minoxidil topical foam used once daily Receives: Drug: minoxidil |
| 2% MTS | Active comparator | 2% minoxidil topical solution twice daily use Receives: Drug: minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of target area non-vellus hair count (TAHC) [n/cm²] after 24 weeks
Measured: 24 weeks
Secondary outcomes (4)
Assessing the investigational products safety by means of clinical examination (local intolerance, facial hypertrichosis, AE, SAE) and blood Minoxidil level (baseline + week 24)
Measured: 24 weeks
Change of cumulative hair width in non-vellus hair (TAHW) after 24 weeks
Measured: 24 weeks
Global expert panel rating of change in scalp coverage via assessment of global photographs
Measured: 24 weeks
Volunteer questionnaire rating for administration and contentment of the study product
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startJun 2008
- Primary completionFeb 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958750
- Sponsor's protocol ID
- CRC-AGA01
- Other IDs
- EudraCT: 2008-001770-33
- Status last verified
- Aug 2009
- First submitted
- 12 Aug 2009
- Last updated
- 18 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator-initiated Single Blind, Two-armed, Randomized Phase 3 Clinical Trial to Compare Efficacy of 5% Minoxidil Topical Foam (5% Mtf) Once Daily Versus 2% Minoxidil Topical Solution (2% Mts) Twice Daily in Application on Females With Slightly to Moderate Androgenetic Alopecia Concerning Hair Volume
- ClinicalTrials.gov ID
- NCT00958750
- Acronym / sponsor ID
- CRC-AGA01
- Conditions
- Androgenetic Alopecia, Female Pattern Hair Loss
- Keywords
- Androgenetic alopecia, female pattern hair loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Not posted in the source record
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 determine in women the risk/benefit profile and non-inferiority of a topical 5% Minoxidil foam formulation applied once daily for the treatment of androgenetic alopecia in comparison to 2% MTS used twice daily, using objective and subjective efficacy measures and safety assessments for a study period of 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% MTF | Active comparator | Drug: minoxidil5% minoxidil topical foam used once daily |
| 2% MTS | Active comparator | Drug: minoxidil2% minoxidil topical solution twice daily use |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female, age 18 or older, in general good health
- Exhibits AGA based on a discernable decrease in hair density on the top of the scalp, relative to the sides and back of the scalp, with scalp hair density in involved area D3 to D6 on the Savin Density Scale (See Appendix 1)
- Hair density equal or less than 220 hairs /cm2 measured with TrichoScan
- Subjects who give their consent to the study after thoroughly clarification and who personally signed and dated the informed consent document indicating that the subject (or a legally acceptable representative), has been informed of all pertinent aspects of the trial
- Women of childbearing potential, who practice an effective method of contraception for at least five consecutive weeks prior to the study entry and during the study with one of the following methods:
Key exclusion criteria (12 listed)
- Known to be hypersensitive to Minoxidil, hair dye (P-Phenylendiamin), Tattoo ink, propylene glycol, fragrances, hair gel or any vehicle components.
- Current or 4 weeks dated back use of local treatment (drug or cosmetically) in the target region interfering with the study product or examination method (corticosteroids, Aminexil, Minoxidil, medical shampoos, topical estrogen, Ketoconazol)
- Current or 3 months dated back use of systemic treatment (drugs or dietary supplement) taken for more than 2 consecutive weeks interfering with the study product or examination method (beta blocker, Cimetidine, Diazoxid, Isotretinoin, corticosteroids, vitamin A intake above 10000 IU per day)
- Within past 6 month receiving of chemotherapy/cytotoxic agents as well as radiation and/or laser/surgical therapy of the scalp
- Current or prior enrollment in any other investigational medication (drug) study within the last 4 weeks
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 |
|---|---|---|
| minoxidilthe investigators compared two different formulations and concentrations of minoxidil in this study | Drug | 2% MTS, 5% MTF |
Primary outcome
Change of target area non-vellus hair count (TAHC) [n/cm²] after 24 weeks
Time frame: 24 weeks
4 secondary outcomes
Assessing the investigational products safety by means of clinical examination (local intolerance, facial hypertrichosis, AE, SAE) and blood Minoxidil level (baseline + week 24)
Time frame: 24 weeks
Change of cumulative hair width in non-vellus hair (TAHW) after 24 weeks
Time frame: 24 weeks
Global expert panel rating of change in scalp coverage via assessment of global photographs
Time frame: 24 weeks
Volunteer questionnaire rating for administration and contentment of the study product
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2011.
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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 Phase 3 study testing minoxidil in people with Androgenetic Alopecia and Female Pattern Hair Loss, run by Charite University, Berlin, Germany at 1 site in Germany.
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 12 inclusion and 12 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 18 Nov 2011. 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 Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of target area non-vellus hair count (TAHC) [n/cm²] after 24 weeks (time frame: 24 weeks). 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 18 Nov 2011.