Female Pattern AlopeciaPhase 3NCT01655108
Efficacy and Safety of Mesotherapy With Minoxidil 0.5%/2ml for Androgenetic Alopecia in Female Patients
A Phase 3 study testing Minoxidil and Saline in people with Female Pattern Alopecia, run by Brasilia University Hospital at 1 site in Brazil.
Trial summary
This study aims to investigate the effectiveness and safety of mesotherapy for the treatment of female pattern alopecia. Sixty female subjects between 18 and 65 years diagnosed with female pattern hair loss will undergo mesotherapy sessions weekly for ten weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Female Pattern Alopecia
- What is being tested?
- Minoxidil and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2012to Dec 2013
- 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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women from 18 to 65 years old
- Androgenetic Alopecia (female pattern hair loss)
Who cannot join
- patients with alopecia areata or cicatricial alopecia
- pregnancy and breastfeeding
- have undergone any specific treatment in the last 06 months
- use of drugs with anti-androgenic properties
- patients with signs or symptoms of hyper-androgynism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BLIND RANDOMIZED COMPARATIVE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MESOTHERAPY MINOXIDIL HAIR WITH 0.5% / 2ML VERSUS PLACEBO IN THE TREATMENT OF FEMALE ANDROGENETIC ALOPECIA
This study aims to investigate the effectiveness and safety of mesotherapy for the treatment of female pattern alopecia.
- Sixty female subjects between 18 and 65 years diagnosed with female pattern hair loss will undergo mesotherapy sessions weekly for ten weeks.
- One group will receive 0.5%/2ml minoxidil application and a control group will receive application of placebo (saline 0.9%).
- Biopsy of the scalp, trichogram and trichoscopy (Fotofinder) will be performed before and 08 weeks after treatment as a method objective evaluation of the response
Read the detailed description
This is a trial that aims to analyze the efficacy and safety of mesotherapy with minoxidil 0,5% versus placebo for androgenetic alopecia in female patients.
The patients and the investigators who analyzes complementary exams are blind.
- Clinical criteria, photo, 4mm biopsia, trichogram and trichoscopy are perfomed before patients are randomized into two arms :
- Group 1 (Placebo): 30 patients who will have intradermal injections in the scalp of saline 0.9%
- Group 2 (Active Drug): 30 patients who will receive intradermal injections in the scalp with minoxidil 0.5%/2ml Eight weeks after the last session patients will be recruited for repeat the exams and perform a self-assessment of both the effect on hair growth and the effect on hair loss.
- Conditions
- Female Pattern Alopecia
- Being tested
- Minoxidil, Saline
- Keywords
- Androgenetic Alopecia, Mesotherapy, Minoxidil, Trichogram
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinoxidilDrug
Minoxidil 0.5% /2ml intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks
SalineDrug
Physiological saline solution 0.9% , intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | After having been properly diagnostic as having androgenetic alopecia, through biopsy of the scalp, trichogram and trichoscopy and randomized in the placebo group, thirty women will be subjected to intradermal application (mesotherapy) of saline; ten sessions will be held at weekly intervals. Eight weeks after the last session will be repeated all the tests for comparison of results. Receives: Drug: Saline |
| Minoxidil 0.5% /2ml | Active comparator | After having been properly diagnostic as having androgenetic alopecia, through biopsy of the scalp, trichogram and trichoscopy and randomized in the drug active group, thirty women will be subjected to intradermal application (mesotherapy) of minoxidil 0.5%/2ml; ten sessions will be held at weekly intervals. Eight weeks after the last session will be repeated all the tests for comparison of results. Receives: Drug: Minoxidil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in hair density
Six weeks after the last session of mesotherapy patients will be subjected to control examinations to evaluation of results. Scalp biopsy to determine the terminal-vellus ratio, trichogram to assess the percentage of anagen hair, telogen and dystrophic and Trichoscan will be performed to see if there was improvement in hair density
Measured: Sixteen weeks
Secondary outcomes (1)
Mesotherapy safety
In each session of mesotherapy, blood pressure and cardiac frequency at baseline and 10 min after application of the drug will be measured to assess the safety profile of the solution of minoxidil to 0.5% when injected intradermally.
Any adverse effect reported will be recorded on specific clinical form
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Pattern 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brasilia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Izelda Maria Carvalho Costa, Brasilia University Hospital
- Investigators
- Barbara Uzel, M.D, Principal investigator, University of BrasiliaIzelda Costa, Ph.D, Study director, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655108
- Sponsor's protocol ID
- HUB-UnB TrichoGroup 1
- Status last verified
- Sep 2013
- First submitted
- 24 Jul 2012
- Last updated
- 25 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BLIND RANDOMIZED COMPARATIVE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MESOTHERAPY MINOXIDIL HAIR WITH 0.5% / 2ML VERSUS PLACEBO IN THE TREATMENT OF FEMALE ANDROGENETIC ALOPECIA
- ClinicalTrials.gov ID
- NCT01655108
- Acronym / sponsor ID
- HUB-UnB TrichoGroup 1
- Conditions
- Female Pattern Alopecia
- Keywords
- Androgenetic Alopecia, Mesotherapy, Minoxidil, Trichogram
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Brasilia University HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 1 Aug 2012 (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.
This study aims to investigate the effectiveness and safety of mesotherapy for the treatment of female pattern alopecia.
- Sixty female subjects between 18 and 65 years diagnosed with female pattern hair loss will undergo mesotherapy sessions weekly for ten weeks.
- One group will receive 0.5%/2ml minoxidil application and a control group will receive application of placebo (saline 0.9%).
- Biopsy of the scalp, trichogram and trichoscopy (Fotofinder) will be performed before and 08 weeks after treatment as a method objective evaluation of the response
Detailed description
This is a trial that aims to analyze the efficacy and safety of mesotherapy with minoxidil 0,5% versus placebo for androgenetic alopecia in female patients.
The patients and the investigators who analyzes complementary exams are blind.
- Clinical criteria, photo, 4mm biopsia, trichogram and trichoscopy are perfomed before patients are randomized into two arms :
- Group 1 (Placebo): 30 patients who will have intradermal injections in the scalp of saline 0.9%
- Group 2 (Active Drug): 30 patients who will receive intradermal injections in the scalp with minoxidil 0.5%/2ml Eight weeks after the last session patients will be recruited for repeat the exams and perform a self-assessment of both the effect on hair growth and the effect on hair loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Drug: SalineAfter having been properly diagnostic as having androgenetic alopecia, through biopsy of the scalp, trichogram and trichoscopy and randomized in the placebo group, thirty women will be subjected to intradermal application (mesotherapy) of saline; ten sessions will be held at weekly intervals. Eight weeks after the last session will be repeated all the tests for comparison of results. |
| Minoxidil 0.5% /2ml | Active comparator | Drug: MinoxidilAfter having been properly diagnostic as having androgenetic alopecia, through biopsy of the scalp, trichogram and trichoscopy and randomized in the drug active group, thirty women will be subjected to intradermal application (mesotherapy) of minoxidil 0.5%/2ml; ten sessions will be held at weekly intervals. Eight weeks after the last session will be repeated all the tests for comparison of results. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Women from 18 to 65 years old
- Androgenetic Alopecia (female pattern hair loss)
Key exclusion criteria (5 listed)
- patients with alopecia areata or cicatricial alopecia
- pregnancy and breastfeeding
- have undergone any specific treatment in the last 06 months
- use of drugs with anti-androgenic properties
- patients with signs or symptoms of hyper-androgynism
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 |
|---|---|---|
| MinoxidilMinoxidil 0.5% /2ml intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks | Drug | Minoxidil 0.5% /2ml |
| SalinePhysiological saline solution 0.9% , intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks | Drug | Saline |
Primary outcome
Increase in hair density
Time frame: Sixteen weeks
Six weeks after the last session of mesotherapy patients will be subjected to control examinations to evaluation of results. Scalp biopsy to determine the terminal-vellus ratio, trichogram to assess the percentage of anagen hair, telogen and dystrophic and Trichoscan will be performed to see if there was improvement in hair density
1 secondary outcome
Mesotherapy safety
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 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.
Barbara Uzel, M.D principal investigator
University of Brasilia
Izelda Costa, Ph.D study director
University of Brasilia
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 and Saline in people with Female Pattern Alopecia, run by Brasilia University Hospital at 1 site in Brazil.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Sep 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 Brazil. 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 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?
Results are not available in the source record.
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?
Increase in hair density (time frame: Sixteen 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 25 Sep 2013.