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

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.

Study Overview

• Status: Recruiting
• Conditions: Androgenic Alopecia
• Intervention / Treatment: Procedure: MESOTHERAPY (INJECTIONS WITH SYRINGE AND NEEDLE); Procedure: MMP (INJECTIONS WITH A TATTOO MACHINE)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: SAMIR ARBACHE, PhD; Phone Number: 12 981221011; Email: samir.arbache@gmail.com

Study Locations

• Brazil
  • São Paulo
    • São José dos Campos, São Paulo, Brazil, 12245-760
      • Recruiting
      • Clinica Dermatologica Arbache
      • Contact: Samir Arbache, PhD; Phone Number: +55 12 981221011; Email: samir.arbache@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); After the anesthetic block, dutasteride will be injected using syringes and needles into the area of alopecia.
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); After the anesthetic block, dutasteride will be injected through needling performed by a tattoo machine in the area of alopecia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?	1 year

Collaborators and Investigators

• Sponsor: Clinica Dermatologica Arbache ltda

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 2, 2025

Study Registration Dates

• First Submitted: October 22, 2023
• First Submitted That Met QC Criteria: October 25, 2023
• First Posted (Actual): October 31, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Dutasteride; Mesotherapy; Administration, Cutaneous
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: 004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No