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

Last updated: October 30, 2023
Sponsor: Clinica Dermatologica Arbache ltda
Overall Status: Active - Recruiting

Phase

4

Condition

Male Pattern Baldness

Alopecia

Hair Loss

Treatment

MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE)

MMP (INJECTIONS WITH A TATTOO MACHINE)

Clinical Study ID

NCT06110377
004
  • Ages 18-65
  • Male
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy volunteers male patients.
  • Aged 18 to 65 years.
  • Patients with male androgenetic alopecia (grades III - V of the Norwood/Hamiltonscale)
  • 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 12months or without topical treatment for more than 6 months before the start of thestudy.
  • Allow the creation of two micro tattoos (maximum size of 1 mm each, resembling a hairyinfundibulum) in the area that will be treated, in order to standardize thetrichoscopic analysis.
  • With the aim of photographic standardization, the patient must agree to have theirhair 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 monthsafter the last intervention,
  • Patient must abstain from drinking alcoholic beverages, abstain from using inhaled orinjectable drugs, abstain from using illicit drugs within 30 days of entering thestudy,
  • Patients without a psychiatric diagnosis and who behave appropriately during theinterview,
  • Signs of good hygiene and that have the ability to keep the areas undergoing treatmentclean 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 diseaseor ulcerative colitis,
  • Absence of immunosuppression, for example: lymphoma, transplant therapy, chroniccorticosteroid use, Wiskott-Aldrich Syndrome or uncontrolled malignancy,
  • Patients/participants with previously known allergies or those detected during theinterventions (anesthetics, topical antibiotics or other medications used in thetrials),
  • Absence of clinically significant cardiovascular disease (e.g. previous myocardialinfarction), absence of coagulopathy or use of anticoagulants, absence of neurologicaldisease (e.g. stroke, cerebral ischemia), absence of renal, hepatic or endocrinedisease (e.g. example, diabetes).
  • Patient/participant with medical conditions not mentioned, which in the investigator'sview, prohibit participation in the study.
  • Signature of informed consent

Exclusion

Exclusion Criteria:

  • Detection during the test of allergy to the medicines used (anesthetics, topicalantibiotics or other medicines used in the tests),
  • Breach of protocol, inappropriate conduct that compromises participant safety orinterferes with the interpretation of study results,
  • Any illness or condition, which in the judgment of the investigators, interferes withthe participant's ability to complete or terminate the investigation.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE)
Phase: 4
Study Start date:
October 30, 2023
Estimated Completion Date:
April 02, 2025

Connect with a study center

  • Clinica Dermatologica Arbache

    São José dos Campos, São Paulo 12245-760
    Brazil

    Active - Recruiting

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