Bicalutamide 25 mg combined with minoxidil 1 mg versus minoxidil 1 mg for female pattern hair loss: A randomized double-blind clinical trial.
Study Design
- Tipo de Estudo
- RCT
- Tamanho da Amostra
- 74
- Duração
- 24 weeks
- Intervenção
- Bicalutamide 25 mg combined with minoxidil 1 mg versus minoxidil 1 mg for female pattern hair loss: A randomized double-blind clinical trial. Bicalutamide 25mg/day + minoxidil 1mg/day
- Comparador
- Placebo
- Direção do Efeito
- Neutral
- Risco de Viés
- Low
Abstract
BACKGROUND: Antiandrogenic drugs are often used to treat female pattern hair loss (FPHL) despite limited evidence supporting their use. There is growing interest in bicalutamide for this purpose, but its efficacy in treating FPHL has not been evaluated in clinical trials. OBJECTIVES: To assess the efficacy of 25 mg/d bicalutamide combined with 1 mg/d minoxidil compared to 1 mg/d minoxidil monotherapy over 24 weeks for FPHL treatment. METHODS: A randomized, controlled, double-blind clinical trial enrolled 74 participants into 2 groups: bicalutamide 25 mg/d plus minoxidil 1 mg/d or placebo plus minoxidil 1 mg/d for 24 weeks. The primary outcome was the change in total hair density in the target area. RESULT: Sixty-four (86.5%) participants completed the study (32 per group). There was a mean increase of 18.1 hairs/cm2 in the bicalutamide-minoxidil group and 21.5 hairs/cm2 in the minoxidil group (P = .86). According to the global consensus analysis of clinical photographs, there was no difference in clinical improvement between the groups (P = .78). LIMITATIONS: Single-center study and short follow-up period (24 weeks). CONCLUSION: Bicalutamide 25 mg/d combined with minoxidil 1 mg/d did not provide additional improvement in FPHL treatment compared to minoxidil alone after 24 weeks.
Full Text
Figures
Fig 1
CONSORT flow diagram for the randomized double-blind trial comparing bicalutamide 25 mg combined with oral minoxidil 1 mg versus minoxidil 1 mg alone for female pattern hair loss.
flowchart
Fig 2
Hair density or trichoscopic measurements comparing the bicalutamide plus minoxidil combination group with minoxidil monotherapy for female pattern hair loss.
chart
Fig 3
Clinical photographs or global improvement scores from the bicalutamide-minoxidil combination trial, showing hair regrowth outcomes at study endpoints.
photographTables
Table I
| Variables | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age (y), mean (SD) | 38.7 (12.3) | 35.6 (10.6) | 37.2 (11.5) |
| BMI (m/kg2), mean (SD) | 26.6 (5.1) | 27.1 (2.7) | 26.9 (5.4) |
| Skin phototype, | |||
| I-II | 13 (35.1) | 13 (35.1) | 26 (35.2) |
| III | 17 (45.9) | 14 (37.8) | 31 (41.9) |
| IV-V | 7 (18.9) | 10 (27.0) | 17 (23.0) |
| Menopaused, | 10 (27.0) | 4 (10.8) | 14 (18.9) |
| Current smoking, | 0 (−) | 4 (10.8) | 4 (5.4) |
| Heart rate (bpm), mean (SD) | 75.2 (11.3) | 75.2 (10.8) | 75.2 (11.0) |
| BP (mmHg), mean (SD) | |||
| Systolic | 119.5 (13.9) | 119.7 (18.8) | 119.6 (16.4) |
| Diastolic | 78.2 (7.8) | 77.6 (17.0) | 77.9 (13.2) |
| Sinclair scale, | |||
| II | 26 (70.3) | 23 (62.2) | 49 (66.2) |
| III | 8 (21.6) | 12 (32.4) | 20 (27.0) |
| IV | 3 (8.1) | 2 (5.4) | 5 (6.8) |
| WAA-QoL, mean (SD) | 56.5 (22.0) | 53.9 (22.6) | 55.2 (22.1) |
| Hair shedding scale, | |||
| I-II | 3 (8.1) | 2 (5.4) | 5 (6.8) |
| III | 2 (5.4) | 4 (10.8) | 6 (8.1) |
| IV | 11 (29.7) | 10 (27.0) | 21 (28.4) |
| V | 14 (37.8) | 16 (43.2) | 30 (40.5) |
| VI | 7 (18.9) | 5 (13.5) | 12 (16.2) |
| Hair density (cm2), mean (SD) | 188.2 (55.9) | 188.6 (57.4) | 188.4 (56.3) |
Table II
| Variables | Group 1 ( | Group 2 ( | Difference (95% CI) | |||
|---|---|---|---|---|---|---|
| Baseline | Wk 24 | Baseline | Wk 24 | |||
| Hair density (cm2), mean (SD) | 188.2 (55.9) | 201.1 (60.4) | 188.6 (57.4) | 205.3 (68.9) | −3.0 (−29.0 to 34.9) | .855 |
| GIS, | ||||||
| Worse | NA | 2 (5) | NA | 2 (5) | NA | .776 |
| No change | NA | 18 (49) | NA | 15 (41) | NA | |
| Mild improved | NA | 12 (32) | NA | 16 (43) | NA | |
| Much improved | NA | 5 (14) | NA | 3 (8) | NA | |
| Very much improved | NA | 0 (−) | NA | 1 (3) | NA | |
| Hair shedding scale, | ||||||
| I-II | 3 (8) | 9 (28) | 2 (5) | 8 (25) | NA | |
| III | 2 (5) | 16 (50) | 4 (11) | 8 (25) | NA | |
| IV | 11 (30) | 6 (19) | 10 (27) | 10 (31) | NA | |
| V | 14 (38) | 1 (3) | 16 (43) | 5 (16) | NA | |
| VI | 7 (19) | 0 (−) | 5 (14) | 1 (3) | NA | |
| WAA-QoL, mean (SD) | 56.5 (22.0) | 26.4 (21.9) | 53.9 (22.6) | 29.0 (22.5) | −2.7 (−13.5 to 8.1) | .628 |
| Heart rate (bpm), mean (SD) | 75.2 (11.3) | 79.5 (10.9) | 75.2 (10.8) | 78.2 (10.2) | 1.3 (−3.9 to 6.4) | .623 |
| BP (mmHg), mean (SD) | ||||||
| Systolic | 119.5 (13.9) | 120.3 (12.2) | 119.7 (18.8) | 119.4 (15.6) | 0.4 (−6.5 to 7.2) | .914 |
| Diastolic | 78.2 (7.8) | 76.2 (8.7) | 74.0 (15.5) | 77.6 (17.0) | −1.3 (−6.1 to 3.6) | .609 |
Table III
| Variables | Group 1 | Group 2 | Total | |
|---|---|---|---|---|
| First visit (4th wk) | ||||
| Gastrointestinal symptoms, | 8 (22) | 7 (19) | .778 | 15 (20) |
| Hair shedding, | 6 (16) | 14 (38) | 20 (27) | |
| Last visit (24th wk) | ||||
| Facial hypertrichosis, | 18 (49) | 27 (73) | 45 (61) | |
| Extrafacial hypertrichosis, | 11 (30) | 15 (41) | .465 | 26 (35) |
| Edema, | 4 (11) | 4 (11) | .999 | 8 (11) |
| Headache, | 3 (8) | 5 (14) | .711 | 8 (11) |
| Menstrual abnormality, | 4 (11) | 4 (11) | .999 | 8 (11) |
| Decreased libido, | 3 (8) | 1 (3) | .615 | 4 (5) |
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