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

NCT06110377 | Unknown Phase 4

• 1 other identifier: 004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Androgenic Alopecia

Keywords

Dutasteride; Administration, Cutaneous; Mesotherapy

Outcome Measures

Primary Outcomes (2)

• HAIR DENSITY

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

  1 year

• HAIR THICKNESS

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

  1 year

Secondary Outcomes (1)

• Sexual effects

  1 year

Study Arms (2)

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.

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.

Procedure: MMP (INJECTIONS WITH A TATTOO MACHINE)

Interventions

MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE) PROCEDURE

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

MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE)

MMP (INJECTIONS WITH A TATTOO MACHINE) PROCEDURE

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

MMP (INJECTIONS WITH TATTOO MACHINE)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: yes
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinica Dermatologica Arbache ltda: lead

Study Sites (1)

Clinica Dermatologica Arbache

São José dos Campos, São Paulo, 12245-760, Brazil

RECRUITING

MeSH Terms

Conditions

Alopecia

Interventions

Mesotherapy; Injections; Syringes; Needles; Matrix Metalloproteinases

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Cosmetic Techniques; Injections, Subcutaneous; Drug Administration Routes; Drug Therapy; Equipment and Supplies; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases

Central Study Contacts

SAMIR ARBACHE, PhD

CONTACT

12 981221011; samir.arbache@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: October 22, 2023
• First Posted: October 31, 2023
• Study Start: October 30, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 2, 2025
• Last Updated: November 1, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)