Treatment for male hair loss using dutasteride injections

MALE ANDROGENETIC ALOPECIA - Treatment With Dutasteride Injections: Mesotherapy (Injections With Syringe and Needle) x MMP Technique (Microinjections With Tattoo Machine)

This study is testing whether using a tattoo machine or a regular syringe for dutasteride injections can help Brazilian men aged 18 to 65 with hair loss grow more hair.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Male
• Sponsor: Clinica Dermatologica Arbache ltda (Academic / other)
• Locations: 1 site (São José dos Campos, São Paulo)
• Trial ID: NCT06110377 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of two different techniques for administering dutasteride to treat androgenetic alopecia in Brazilian men aged 18 to 65. The study will compare traditional syringe injections with a novel method using a tattoo machine for mesotherapy. A total of 60 participants will be randomized to receive one of the two treatment methods, with a focus on assessing hair growth outcomes. The trial aims to determine which administration technique yields better results in hair restoration.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy male patients aged 18 to 65 with mild to moderate androgenetic alopecia.

Not a fit: Patients with severe androgenetic alopecia or those currently undergoing other hair loss treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide an effective solution for men suffering from androgenetic alopecia, improving their hair growth and overall confidence.

How similar studies have performed: While there have been studies on dutasteride for hair loss, the specific combination of mesotherapy techniques used in this trial is relatively novel.

Eligibility criteria

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.

Where this trial is running

São José dos Campos, São Paulo

• Clinica Dermatologica Arbache — São José dos Campos, São Paulo, Brazil (Recruiting)

Study contacts

• Study coordinator: SAMIR ARBACHE, PhD

Conditions Androgenic Alopecia; Dutasteride; Administration, Cutaneous; Mesotherapy