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RecruitingNCT06110377MMPUpdated Nov 1, 2023

MALE HAIR LOSS - Treatment With Dutasteride Mesotherapy x Dutasteride MMP Technique (Injections With Tattoo Machine)

A Phase 4 interventional study of MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE) and MMP (INJECTIONS WITH A TATTOO MACHINE) in Androgenic Alopecia, sponsored by Clinica Dermatologica Arbache ltda. Recruiting at 1 site in Brazil. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-01.

Sponsored by Clinica Dermatologica Arbache ltda · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Androgenic Alopecia

Keywords

  • Dutasteride
  • Administration, Cutaneous
  • Mesotherapy
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE)

    After the anesthetic block, dutasteride will be injected using syringes and needles into the area of alopecia.

    Procedure: MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE)

  • Experimental
    MMP (INJECTIONS WITH TATTOO MACHINE)

    After the anesthetic block, dutasteride will be injected through needling performed by a tattoo machine in the area of alopecia.

    Procedure: MMP (INJECTIONS WITH A TATTOO MACHINE)

Interventions

  • ProcedureMESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE)

    After the anesthetic block, dutasteride will be injected using syringes and needles into the area of alopecia.

  • ProcedureMMP (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.

05

What researchers measure

Primary outcomes

  1. HAIR DENSITY

    analysis of hair density (number of follicles) per square centimeter using Trichoscale software (fotofinder) and clinical photographs.

    Time frame: 1 year

  2. HAIR THICKNESS

    measurement of the thickness of hair shafts using Trichoscale software (fotofinder)

    Time frame: 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?

    Time frame: 1 year

06

Study locations

1 of 1 sites recruiting
  • Clinica Dermatologica Arbache
    São José dos Campos, São Paulo 12245-760, Brazil
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06110377
Lead sponsor
Clinica Dermatologica Arbache ltda
Responsible party
Sponsor
First posted
Oct 31, 2023
Start date
Oct 30, 2023 (estimated)
Primary completion
Apr 1, 2024 (estimated)
Completion
Apr 2, 2025 (estimated)
Last update
Nov 1, 2023

Study contacts

SAMIR ARBACHE, PhD
Contact
samir.arbache@gmail.com
12 981221011

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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