This document summarizes a retrospective review of 316 women treated with oral bicalutamide for female pattern hair loss. Bicalutamide is a non-steroidal antiandrogen that does not have estrogenic or androgenic activity. The review found bicalutamide to have a favorable safety profile, with mild increases in liver enzymes in a small number of patients. For patients who took bicalutamide for over 6 months (n=138), there was a mean reduction in hair loss of 28.9% after 2 years based on clinical photographs assessed by dermatologists. The authors conclude that bicalutamide can be considered an effective and safe treatment for female pattern hair loss.

1. BICALUTAMIDE: A POTENTIAL NEW ORAL
ANTIANDROGENIC DRUG FOR
FEMALE PATTERN HAIR LOSS.
JOURNAL CLUB
MIGUEL ARISTIZABAL M.D.
ADEI - AESTHETICS & DERMATOLOGY INSTITUTE
UNIVERSIDAD DEL ROSARIO
BOGOTA - COLOMBIA

3. FPHL
• Androgen mediated miniaturization of the hair follicle: spironolactone,
cyproterone acetate, flutamide.
• Bicalutamide: non-steroidal, pure anti-androgen
• It has no estrogenic, progestational, glucocorticoid, mineralocorticoid or androgenic
activity and does not inhibit steroid 5α- reductase
• Peripherally selective: does not cross the blood-brain-barrier and thus has little effect
on serum LH and testosterone

5. Flutamide:
• Dose-related, marked increases in
serum luteinizing hormone (LH) and
testosterone as a consequence of the central
inhibition of the negative feedback effects of
androgens on the hypothalamic-pituitary-
testes axis.
Flutamide

6. OBJECTIVE
• To evaluate the safety of bicalutamide in FPHL conducting a retrospective review
of all patients prescribed oral bicalutamide at a specialist hair clinic between April
2013 and October 2019.
• Efficacy in the cohort receiving bicalutamide for more than 6 months.

7. MATERIALS AND METHODS

8. PATIENT DEMOGRAPHICS
• 316 women: standard dose 10mg daily.

9. MATERIALS AND METHODS
• Mean duration of treatment was 6.21 months (range 2-69 months).
• 308 pts: bicalutamide + minoxidil.
• 172 pts: bicalutamide + spironolactone.
• 6 pts: bicalutamide monotherapy.
• Baseline blood tests (full blood count, liver and renal function) and 3-monthly
monitoring blood tests were performed.

10. RESULTS

12. EFFICACY COHORT
• n=138
• n=135: bicalutamide + minoxidil.
• n=100: bicalutamide + spironolactone
• n=3: bicalutamide monotherapy.
• Clinical photographs taken at 3-monthly intervals were reviewed by 2
dermatologists to assess the Sinclair stage

13. EFFICACY RESULTS
• The mean Sinclair stage at baseline was 2.77.
• The mean reduction in Sinclair stage was 0.18 (6.5%) at 3 months, 0.47 (17.0%) at
6 months, 0.56 (20.2%) at 9 months, 0.68 (24.5%) at 12 months and 0.80 (28.9%)
at 2 years.

14. CONCLUSIONS
• Oral bicalutamide has a favorable safety profile when used to treat FPHL.
• More than 95% of patients who started treatment with bicalutamide adhered to
treatment.
• Thirteen patients discontinued the medication due to adverse effects, some of which
may have been related to minoxidil rather than bicalutamide.
• In contrast to flutamide, the elevation in liver transaminases was mild in all cases.
• Bicalutamide can be considered as an antiandrogen in the treatment of FPHL.
• The use of concomitant medications and the retrospective design of this
study limit the evaluation of efficacy.

16. OBJECTIVE
• Retrospective review of all patients who were receiving OB for FPHL at the hair
clinic between February 2018 and February 2020. Safety profile was analyzed as
the primary objective.
• As a secondary objective, therapeutic response was assessed by the comparison
of photographs at weeks 0 and 24 by three independent dermatologists, using
the Sinclair scale.

17. M & MS
• A total of 44 women receiving OB 25-50 mg daily were included.

18. RESULTS
• Mild increase of liver transaminases in five patients
(11.4%), with self-resolution without discontinuing
tx.
• Other adverse effects included hair shedding in
three patients, transient amenorrhea in two
patients, and endometrial hyperplasia and
headache in one patient.
• No patient discontinued the treatment.

19. RESULTS
• Bicalutamide > 6months n=32: the mean
reduction in the Sinclair scale was 0.81 (27.5%).
• Of the patients receiving OB in monotherapy
(n=3), two maintained a Sinclair stage 2 and one
changed from stage 2 to stage 1

20. CONCLUSIONS
• Hirsutism is currently treated with doses up to 50 mg daily.
• Authors hypothesize that higher doses of OB between 25-50 mg daily have also a
good safety profile and may increase efficacy.
• The limitations of our analysis are the small sample size and the use of
concomitant therapies.