Androgenic AlopeciaPhase 4MMPNCT06110377
MALE HAIR LOSS - Treatment With Dutasteride Mesotherapy x Dutasteride MMP Technique (Injections With Tattoo Machine)
A Phase 4 study testing MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE) and MMP (INJECTIONS WITH A TATTOO MACHINE) in people with Androgenic Alopecia, run by Clinica Dermatologica Arbache ltda at 1 site in Brazil.
Trial summary
This randomized clinical trial carried out on 60 Brazilian men, aged 18 to 65, with mild or moderate androgenetic alopecia. Two techniques for administering dutasteride will be compared, injected by syringes or needles or by needling through tattoo machines. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE) and MMP (INJECTIONS WITH A TATTOO MACHINE)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Oct 2023to 2 Apr 2025
- Phase
- Phase 4
- 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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteers male patients.
- Aged 18 to 65 years.
- Patients with male androgenetic alopecia (grades III - V of the Norwood/Hamilton scale)
- Commitment not to initiate any other treatment, topical, systemic or intralesional, that interferes with hair growth during the study period.
- Patient without systemic treatment for AGA (5 reductase inhibitors) for more than 12 months or without topical treatment for more than 6 months before the start of the study.
- Allow the creation of two micro tattoos (maximum size of 1 mm each, resembling a hairy infundibulum) in the area that will be treated, in order to standardize the trichoscopic analysis.
Show all 23Show fewer
- With the aim of photographic standardization, the patient must agree to have their hair cut in a standardized way in the first and last interventions.
- Patient about to get his partner pregnant.
- Patient must refrain from donating blood during the investigation and up to 6 months after the last intervention,
- Patient must abstain from drinking alcoholic beverages, abstain from using inhaled or injectable drugs, abstain from using illicit drugs within 30 days of entering the study,
- Patients without a psychiatric diagnosis and who behave appropriately during the interview,
- Signs of good hygiene and that have the ability to keep the areas undergoing treatment clean until they heal,
- Patients who understand and speak Portuguese,
- Patients with realistic expectations regarding the final benefits of treatment,
- Needle phobia,
- Independent patient, eliminating the need for tutoring or legal representative,
- Absence of chronic viral diseases, for example HIV, hepatitis B or hepatitis C,
- Absence of other skin diseases, for example lichen planus, psoriasis, Crohn's disease or ulcerative colitis,
- Absence of immunosuppression, for example: lymphoma, transplant therapy, chronic corticosteroid use, Wiskott-Aldrich Syndrome or uncontrolled malignancy,
- Patients/participants with previously known allergies or those detected during the interventions (anesthetics, topical antibiotics or other medications used in the trials),
- Absence of clinically significant cardiovascular disease (e.g. previous myocardial infarction), absence of coagulopathy or use of anticoagulants, absence of neurological disease (e.g. stroke, cerebral ischemia), absence of renal, hepatic or endocrine disease (e.g. example, diabetes).
- Patient/participant with medical conditions not mentioned, which in the investigator's view, prohibit participation in the study.
- Signature of informed consent
Who cannot join
- Detection during the test of allergy to the medicines used (anesthetics, topical antibiotics or other medicines used in the tests),
- Breach of protocol, inappropriate conduct that compromises participant safety or interferes with the interpretation of study results,
- Any illness or condition, which in the judgment of the investigators, interferes with the participant's ability to complete or terminate the investigation.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Clinica Dermatologica Arbache
São José dos Campos, São Paulo, 12245-760
Samir Arbache, PhD, +55 12 981221011, samir.arbache@gmail.com
About this study
Official title: MALE ANDROGENETIC ALOPECIA - Treatment With Dutasteride Injections: Mesotherapy (Injections With Syringe and Needle) x MMP Technique (Microinjections With Tattoo Machine)
This randomized clinical trial carried out on 60 Brazilian men, aged 18 to 65, with mild or moderate androgenetic alopecia. Two techniques for administering dutasteride will be compared, injected by syringes or needles or by needling through tattoo machines.
- Conditions
- Androgenic Alopecia
- Being tested
- MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE), MMP (INJECTIONS WITH A TATTOO MACHINE)
- Keywords
- Dutasteride, Administration, Cutaneous, Mesotherapy
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE)Procedure or surgery
After the anesthetic block, dutasteride will be injected using syringes and needles into the area of alopecia.
MMP (INJECTIONS WITH A TATTOO MACHINE)Procedure or surgery
After the anesthetic block, dutasteride will be injected through needling performed by a tattoo machine in the area of alopecia.
| Study group | Role | What they receive |
|---|---|---|
| MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE) | Active comparator | After the anesthetic block, dutasteride will be injected using syringes and needles into the area of alopecia. Receives: Procedure: MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE) |
| MMP (INJECTIONS WITH TATTOO MACHINE) | Experimental | After the anesthetic block, dutasteride will be injected through needling performed by a tattoo machine in the area of alopecia. Receives: Procedure: MMP (INJECTIONS WITH A TATTOO MACHINE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAIR DENSITY
analysis of hair density (number of follicles) per square centimeter using Trichoscale software (fotofinder) and clinical photographs.
Measured: 1 year
HAIR THICKNESS
measurement of the thickness of hair shafts using Trichoscale software (fotofinder)
Measured: 1 year
Secondary outcomes (1)
Sexual effects
Assessment of sexual adverse effects (sexual impotence or decreased libido) through Likert questionnaire: The answer will be dichotomous, did you feel any sexual effects (impotence or decreased libido during your treatment? Yes or no?
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start30 Oct 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion2 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized study carried out on 60 men. Two techniques for administering dutasteride will be compared, injected by syringes or needles (mesotherapy) or needling using the MMP technique (through tattoo machines)
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Dermatologica Arbache ltda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06110377
- Sponsor's protocol ID
- 004
- Acronym
- MMP
- Status last verified
- Oct 2023
- First submitted
- 22 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MALE ANDROGENETIC ALOPECIA - Treatment With Dutasteride Injections: Mesotherapy (Injections With Syringe and Needle) x MMP Technique (Microinjections With Tattoo Machine)
- ClinicalTrials.gov ID
- NCT06110377
- Acronym / sponsor ID
- MMP / 004
- Conditions
- Androgenic Alopecia
- Keywords
- Dutasteride, Administration, Cutaneous, Mesotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Clinica Dermatologica Arbache ltdaUniversity, hospital or other
- Study start
- 30 Oct 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 2 Apr 2025 (estimated)
- First posted
- 31 Oct 2023 (actual)
- 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 randomized clinical trial carried out on 60 Brazilian men, aged 18 to 65, with mild or moderate androgenetic alopecia. Two techniques for administering dutasteride will be compared, injected by syringes or needles or by needling through tattoo machines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized study carried out on 60 men. Two techniques for administering dutasteride will be compared, injected by syringes or needles (mesotherapy) or needling using the MMP technique (through tattoo machines)
| Arm | Type | Receives |
|---|---|---|
| MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE) | Active comparator | Procedure: MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE)After the anesthetic block, dutasteride will be injected using syringes and needles into the area of alopecia. |
| MMP (INJECTIONS WITH TATTOO MACHINE) | Experimental | Procedure: MMP (INJECTIONS WITH A TATTOO MACHINE)After the anesthetic block, dutasteride will be injected through needling performed by a tattoo machine in the area of alopecia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Healthy volunteers male patients.
- Aged 18 to 65 years.
- Patients with male androgenetic alopecia (grades III - V of the Norwood/Hamilton scale)
- Commitment not to initiate any other treatment, topical, systemic or intralesional, that interferes with hair growth during the study period.
- Patient without systemic treatment for AGA (5 reductase inhibitors) for more than 12 months or without topical treatment for more than 6 months before the start of the study.
Key exclusion criteria (3 listed)
- Detection during the test of allergy to the medicines used (anesthetics, topical antibiotics or other medicines used in the tests),
- Breach of protocol, inappropriate conduct that compromises participant safety or interferes with the interpretation of study results,
- Any illness or condition, which in the judgment of the investigators, interferes with the participant's ability to complete or terminate the investigation.
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 |
|---|---|---|
| MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE)After the anesthetic block, dutasteride will be injected using syringes and needles into the area of alopecia. | Procedure or surgery | MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE) |
| MMP (INJECTIONS WITH A TATTOO MACHINE)After the anesthetic block, dutasteride will be injected through needling performed by a tattoo machine in the area of alopecia. | Procedure or surgery | MMP (INJECTIONS WITH TATTOO MACHINE) |
Primary outcome
HAIR DENSITY
Time frame: 1 year
analysis of hair density (number of follicles) per square centimeter using Trichoscale software (fotofinder) and clinical photographs.
HAIR THICKNESS
Time frame: 1 year
measurement of the thickness of hair shafts using Trichoscale software (fotofinder)
1 secondary outcome
Sexual effects
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Androgenic Alopecia
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE) and MMP (INJECTIONS WITH A TATTOO MACHINE) in people with Androgenic Alopecia, run by Clinica Dermatologica Arbache ltda 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 23 inclusion and 3 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 1 Nov 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 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact SAMIR ARBACHE, PhD (12 981221011, samir.arbache@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HAIR DENSITY (time frame: 1 year). The study lists 2 primary outcomes in all. 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 Nov 2023.