Comparison between treatment with Oral Minoxidil at doses of 1 mg per day and 2 mg per day in the treatment of Female Baldness

Oral Minoxidil 1 mg versus Oral Minoxidil 2 mg for treatment of Female Pattern Alopecia: a randomized, double-blind clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-8sm6kkk

Enrollment

Unknown

Registered

2025-04-04

Start date

2024-06-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Female pattern alopecia

Interventions

This is a planned, controlled, double-blind, parallel, monocentric clinical trial with a 24-week longitudinal follow-up. Eighty female patients aged between 18 and 60 years with a diagnosis of female

D03.383.621.493

Eligibility

Sex/Gender

Female

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Females; age between 18 and 60 years; diagnosis of female pattern alopecia classified between grades II and IV on the Sinclair scale

Exclusion criteria

Exclusion criteria: Patients who have undergone previous treatment for hair loss in the last 6 months; patients diagnosed with systemic arterial hypertension, heart disease or kidney disease; patients with other causes of hair loss; presence of dermatoses on the scalp

Design outcomes

Primary

Measure	Time frame
An increase in terminal hair density in the target area is expected, greater in the group receiving oral minoxidil 2 mg per day when compared with the group receiving oral minoxidil 1 mg per day. The evaluation was performed by counting terminal hairs using trichoscopic photography before treatment with Fotofinder handyscope equipment. This same parameter was reassessed in another consultation after 24 weeks of treatment. Hair counting was performed using specific software (TrichoLAB hair to hair matching technology, Bad Birmach, Germany). Hairs with a thickness greater than 0.04 mm were considered terminal hairs.	—

Measure

Time frame

An increase in terminal hair density in the target area is expected, greater in the group receiving oral minoxidil 2 mg per day when compared with the group receiving oral minoxidil 1 mg per day. The evaluation was performed by counting terminal hairs using trichoscopic photography before treatment with Fotofinder handyscope equipment. This same parameter was reassessed in another consultation after 24 weeks of treatment. Hair counting was performed using specific software (TrichoLAB hair to hair matching technology, Bad Birmach, Germany). Hairs with a thickness greater than 0.04 mm were considered terminal hairs.

—

Secondary

Measure	Time frame
An increase in total hair density is expected in the target area. The evaluation was performed by counting the total number of hairs in the pre-treatment trichoscopic photograph with Fotofinder handyscope equipment. This same parameter was reassessed in an outpatient consultation after 24 weeks of treatment. The hair count was performed with the aid of specific software (TrichoLAB hair to hair matching technology, Bad Birmach, Germany).;Overall improvement in hair coverage assessed by standardized clinical photography. Patients were asked to maintain the same hair style, color, length, and cut throughout the study. The standardized photographs were evaluated by 2 dermatologists blinded about the treatment. Each dermatologist compared the baseline photograph with the 24-week photograph and used a 7-point comparison scale: marked worsening (-3), moderate worsening (-2), slight worsening (-1), no change (0), slight improvement (+1), moderate improvement (+2), and marked improvement (+3).	—

Measure

Time frame

An increase in total hair density is expected in the target area. The evaluation was performed by counting the total number of hairs in the pre-treatment trichoscopic photograph with Fotofinder handyscope equipment. This same parameter was reassessed in an outpatient consultation after 24 weeks of treatment. The hair count was performed with the aid of specific software (TrichoLAB hair to hair matching technology, Bad Birmach, Germany).;Overall improvement in hair coverage assessed by standardized clinical photography. Patients were asked to maintain the same hair style, color, length, and cut throughout the study. The standardized photographs were evaluated by 2 dermatologists blinded about the treatment. Each dermatologist compared the baseline photograph with the 24-week photograph and used a 7-point comparison scale: marked worsening (-3), moderate worsening (-2), slight worsening (-1), no change (0), slight improvement (+1), moderate improvement (+2), and marked improvement (+3).

—

Countries

Brazil

Contacts

Public ContactMarcelo Medeiros

Clinica Sanabria Transplante e Restauração Capilar

zanolli_marcelo@hotmail.com+55(67)981809696

Outcome results

None listed

Source: REBEC (via WHO ICTRP)