Microneedling effect on male baldness.

Not Applicable

• Conditions: Androgenetic alopecia; C17.800.329.937.122

• Registration Number: RBR-3cjbq5
• Lead Sponsor: Hospital São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-26
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

Signature of Written Informed Consent Form and Authorization for Photographs Term prior to any study procedure; men aged between 18 and 60 years, in good health; Clinical diagnosis of moderate male androgenet alopecia (Stage IIIa-IV of the Norwood-Hamilton Scale) with disease onset time less than 10 years; accordance with the conditions of the study, ability to understand and strictly follow the therapeutic guidelines received and availability to attend periodic evaluations.

Exclusion Criteria

Men who do not agree with the conditions of the study or who are unable to understand and strictly follow the therapeutic guidelines received, are not available to attend periodic evaluations or refuse to sign the Written Informed Consent Form and Authorization for Photographs Term; patients suffering from other alopecias, including telogen effluvium; patients with mild disease (stages I and II) or severe disease (stages V to VII of the Norwood-Hamilton Scale); patients who have androgenetic alopecia for more than 10 years; previous use of finasteride or dutasteride in the last 6 months; patients with a current or previous history of malignant or pre-malignant tumors of the scalp; patients that suffer from allergic contact dermatitis to propylene glycol (minoxidil vehicle), minoxidil, tattoo ink, topical or local anesthetic; patients that have dermatoses that may worsen due to the procedure and interfere with the evaluation, such as psoriasis, vitiligo; patients receiving chemotherapy, radiation therapy, corticosteroids or other immunosuppressants.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome 1:Increased hair thickness and follicular density (hairs/cm2) in the halfhead submeted to intervention comparing data from baseline and two weeks after the final intervention. Analysis of the trichoscopic images will be performed using TrichoLAB Hair-to-Hair Matching technology.;Expected outcome 2:Increased hair thickness and follicular density (hairs/cm2) in the halfhead submeted to intervention comparing data from baseline and sexteen weeks after the final intervention. Analysis of the trichoscopic images will be performed using TrichoLAB Hair-to-Hair Matching technology.

Secondary Outcome Measures

Name	Time	Method
Secondary outcomes are not expected.