Androgenetic AlopeciaPhase 2NCT01319370
Effectiveness and Safety of Minoxidil Foam Versus Placebo Foam for Androgenetic Alopecia
A Phase 2 study testing Minoxidil in people with Androgenetic Alopecia, run by Natalie GARCIA BARTELS at 1 site in Germany.
Trial summary
The current study aims to show efficacy of twice daily application of 5% Minoxidil Topical Foam (MTF) formulation compared to placebo in the temple region of male patients with androgenetic alopecia after 24 weeks as well as to gain long-term data on the efficacy and safety of 5% MTF in male subjects with AGA in… Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Minoxidil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Mar 2013
- Phase
- Phase 2
- 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 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, age 18 to 70 year old, in general good health
- Exhibits male AGA based on a discernable hair loss in temple and vertex region rating Hamilton-Norwood Scale III vertex to VI (See Appendix 1)
- Subjects who give their consent to the study after thorough explanation and who personally signed and dated the informed consent document indicating that the subject, has been informed of all pertinent aspects of the trial
- 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 and other trial procedures
- Accepting the Information form plus accepting and signing the Informed Consent form
Who cannot join
- Known to be hypersensitive to minoxidil, hair dye (p-phenylenediamine), tattoo ink, fragrances, hair gel or any vehicle components
- Current or 4 weeks dated back use of medical shampoos or solutions which include Ketoconazole or the like (e. g. Terzolin®) in the target region interfering with the CTM or examination method
- Current or 3 months dated back use of topical treatment in the target regions taken for more then 2 consecutive weeks interfering with the CTM (topical corticosteroids, aminexil, minoxidil, estrogens)
- Current or 3 months dated back use of systemic treatment (drugs or dietary supplement) taken for more than 2 consecutive weeks interfering with the CTM or examination method (beta blocker, cimetidine, diazoxide, isotretionin, corticosteroids, vitamin A intake above 10000 IU per day)
- Current or 12 months dated back use of Finasteride (Propecia®, FinaHair®, etc.), Dutasteride or a similar product
- Within past 12 months undergoing chemotherapy or receiving cytotoxic agents as well as radiation and/or laser/surgical therapy of the scalp
Show all 14Show fewer
- Current or prior enrollment in any other investigational medication (drug) study within the 4 weeks prior to study initiation
- Presence of hair transplants, hair weaves or non-breathable wigs and hair bonding
- Current or 2 months dated back severe diet or presenting a history of eating disorder
- Any dermatological disorders of the scalp in the target region with the possibility of interfering with the CTM or examination method, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars or scalp atrophy
- Untreated persisting hypertension
- Active hair loss or history within the past 3 months including diffuse telogen effluvium, alopecia areata, scarring alopecia
- Other severe, acute or chronic medical condition that may lead to hair loss or interfere with the interpretation of trial results (e. g. untreated hypothyroidism)
- Individuals who are institutionalized by court or regulatory order
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité-Universitätsmedizin Berlin, Clinical Research Center for Hair and Skin Science, Dept. of Dermatology, Venereology and Allergy
Berlin, 10117
About this study
Official title: Investigator-Initiated, Double Blind, Two-Armed, Placebo-Controlled, Randomized Clinical Trial With an Open-Label Extension Phase, to Investigate Efficacy of 5% Minoxidil Topical Foam Twice Daily in Men With Androgenetic Alopecia in the Temple and Vertex Region Concerning Hair Volume Over 24 / 104 Weeks
The current study aims to show efficacy of twice daily application of 5% Minoxidil Topical Foam (MTF) formulation compared to placebo in the temple region of male patients with androgenetic alopecia after 24 weeks as well as to gain long-term data on the efficacy and safety of 5% MTF in male subjects with AGA in temple and vertex region, over a period of 2 years. Objective and subjective efficacy measures will be compared to baseline. Moreover, all patients will get the equal treatment and measurements in the vertex region to enable comparison of the efficacy of 5% Minoxidil Topical Foam in the temples not only to baseline but also to vertex region. Additionally safety assessments will be performed throughout the whole study.
- Conditions
- Androgenetic Alopecia
- Being tested
- Minoxidil, vehicle of 5% Minoxidil topical foam
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinoxidilDrug
1 g of 5% Minoxidil topical foam twice daily over 24 weeks in double-blinded phase and further 80 weeks in open-label-phase
vehicle of 5% Minoxidil topical foamDrug
1 g of vehicle topical foam twice daily over 24 weeks in double-blinded phase and further 80 weeks in open-label-phase
| Study group | Role | What they receive |
|---|---|---|
| vehicle of 5% Minoxidl topical foam | Placebo comparator | vehicel foam in twice daily application in temple and vertex region Receives: Drug: vehicle of 5% Minoxidil topical foam |
| 5% Minoxidil topical foam | Active comparator | 5% Minoxidil topical in twice daily application in temple and vertex region 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 in the temple region (t-TAHC) [n/cm²] compared to baseline after 24 weeks
Measured: Baseline, week 8, week 16, week 24, week 52, week 76, week 104
Secondary outcomes (4)
Assessing the investigational products safety by means of clinical examination (local intolerance, AE, SAE)
Measured: every visit from baseline to week 104
Change of cumulative hair width in non-vellus hair in temple and vertex region (t-TAHW; v-TAHW) [mm/cm²] compared to baseline after 24, 52, 76 and 104 weeks
Measured: Baseline, week 8, week 16, week 24, week 52, week 76, week 104
Change of t-TAHC, v-TAHC, t-TAHW and v-TAHW comparing 5% MTF and Placebo Topical Foam (plaTF) groups
Measured: Baseline, week 8, week 16, week 24, week 52, week 76, week 104
Global expert panel and subjects' rating change in scalp coverage: week 24 compared to baseline, week 104 compared to baseline and week 104 compared to week 24 via assessment of global temple and vertex photographs
Measured: Baseline, week 8, week 16, week 24, week 52, week 76, week 104
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startNov 2010
- Primary completionMar 2013
- Study completionMar 2013
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natalie GARCIA BARTELS
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor-investigator, Natalie GARCIA BARTELS, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319370
- Sponsor's protocol ID
- CRC-AGA02
- Other IDs
- 2010-018291-25
- Status last verified
- Nov 2013
- First submitted
- 18 Mar 2011
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator-Initiated, Double Blind, Two-Armed, Placebo-Controlled, Randomized Clinical Trial With an Open-Label Extension Phase, to Investigate Efficacy of 5% Minoxidil Topical Foam Twice Daily in Men With Androgenetic Alopecia in the Temple and Vertex Region Concerning Hair Volume Over 24 / 104 Weeks
- ClinicalTrials.gov ID
- NCT01319370
- Acronym / sponsor ID
- CRC-AGA02
- Conditions
- Androgenetic Alopecia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Natalie GARCIA BARTELSUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Nov 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 21 Mar 2011 (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 current study aims to show efficacy of twice daily application of 5% Minoxidil Topical Foam (MTF) formulation compared to placebo in the temple region of male patients with androgenetic alopecia after 24 weeks as well as to gain long-term data on the efficacy and safety of 5% MTF in male subjects with AGA in temple and vertex region, over a period of 2 years. Objective and subjective efficacy measures will be compared to baseline. Moreover, all patients will get the equal treatment and measurements in the vertex region to enable comparison of the efficacy of 5% Minoxidil Topical Foam in the temples not only to baseline but also to vertex region. Additionally safety assessments will be performed throughout the whole study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vehicle of 5% Minoxidl topical foam | Placebo comparator | Drug: vehicle of 5% Minoxidil topical foamvehicel foam in twice daily application in temple and vertex region |
| 5% Minoxidil topical foam | Active comparator | Drug: Minoxidil5% Minoxidil topical in twice daily application in temple and vertex region |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male, age 18 to 70 year old, in general good health
- Exhibits male AGA based on a discernable hair loss in temple and vertex region rating Hamilton-Norwood Scale III vertex to VI (See Appendix 1)
- Subjects who give their consent to the study after thorough explanation and who personally signed and dated the informed consent document indicating that the subject, has been informed of all pertinent aspects of the trial
- 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 and other trial procedures
Key exclusion criteria (14 listed)
- Known to be hypersensitive to minoxidil, hair dye (p-phenylenediamine), tattoo ink, fragrances, hair gel or any vehicle components
- Current or 4 weeks dated back use of medical shampoos or solutions which include Ketoconazole or the like (e. g. Terzolin®) in the target region interfering with the CTM or examination method
- Current or 3 months dated back use of topical treatment in the target regions taken for more then 2 consecutive weeks interfering with the CTM (topical corticosteroids, aminexil, minoxidil, estrogens)
- Current or 3 months dated back use of systemic treatment (drugs or dietary supplement) taken for more than 2 consecutive weeks interfering with the CTM or examination method (beta blocker, cimetidine, diazoxide, isotretionin, corticosteroids, vitamin A intake above 10000 IU per day)
- Current or 12 months dated back use of Finasteride (Propecia®, FinaHair®, etc.), Dutasteride or a similar product
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 |
|---|---|---|
| Minoxidil1 g of 5% Minoxidil topical foam twice daily over 24 weeks in double-blinded phase and further 80 weeks in open-label-phase | Drug | 5% Minoxidil topical foam |
| vehicle of 5% Minoxidil topical foam1 g of vehicle topical foam twice daily over 24 weeks in double-blinded phase and further 80 weeks in open-label-phase | Drug | vehicle of 5% Minoxidl topical foam |
Primary outcome
Change of target area non-vellus hair count in the temple region (t-TAHC) [n/cm²] compared to baseline after 24 weeks
Time frame: Baseline, week 8, week 16, week 24, week 52, week 76, week 104
4 secondary outcomes
Assessing the investigational products safety by means of clinical examination (local intolerance, AE, SAE)
Time frame: every visit from baseline to week 104
Change of cumulative hair width in non-vellus hair in temple and vertex region (t-TAHW; v-TAHW) [mm/cm²] compared to baseline after 24, 52, 76 and 104 weeks
Time frame: Baseline, week 8, week 16, week 24, week 52, week 76, week 104
Change of t-TAHC, v-TAHC, t-TAHW and v-TAHW comparing 5% MTF and Placebo Topical Foam (plaTF) groups
Time frame: Baseline, week 8, week 16, week 24, week 52, week 76, week 104
Global expert panel and subjects' rating change in scalp coverage: week 24 compared to baseline, week 104 compared to baseline and week 104 compared to week 24 via assessment of global temple and vertex photographs
Time frame: Baseline, week 8, week 16, week 24, week 52, week 76, week 104
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 7 Nov 2013.
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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 2 study testing Minoxidil in people with Androgenetic Alopecia, run by Natalie GARCIA BARTELS 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 6 inclusion and 14 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 7 Nov 2013. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 in the temple region (t-TAHC) [n/cm²] compared to baseline after 24 weeks (time frame: Baseline, week 8, week 16, week 24, week 52, week 76, week 104). 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 7 Nov 2013.