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. Author manuscript; available in PMC: 2019 Jul 3.
Published in final edited form as: J Drugs Dermatol. 2018 Apr 1;17(4):457–463.

Table 2:

Summarizing the results of studies demonstrating the use of topical FNS for the treatment of AGA.

Author Level of
Evidence
Sample
size
Study
Design
Treatment(s) Assessments Study Outcome and Adverse Events
Mazarella et al. (1997) 2 52 subjects total:
28 male,
24 female,
age range 18–38 y/o
RCT Topical FNS 0.005% vs. placebo for 16 months Physician
Assessments:
Photograph
6 point hair regrowth
scale “Wash test”

Subject
Assessments:
Subjective four-point scale of effectiveness
(0 to 3, with 0 being no effect, and 3 being high effectiveness)
Significant decrease in rate of hair loss in FNS group after 6 months of treatment.
Slight to marked reduction in balding areas in all FNS patients compared to baseline; placebo patients experienced no reduction.
73% of patients in FNS group reported moderate treatment effectiveness, 70% of the placebo group reported no to slight treatment effectiveness.

Adverse Events:
30% subjects withdrew from the placebo group due to treatment non-efficacy.
No reported local or systemic effects in treatment or placebo groups.
Hajheydari et al.
(2009)
2 38 male subjects, mean age 22.8 +/− 3 years RCT Topical FNS 1% with placebo oral tablet vs. oral FNS 1 mg with placebo gel for 6 months Size of bald area
Total hair count
Terminal hair count
Statistically significant increase in total and terminal hair count compared to baseline in both groups after 4 months.
Significant size decrease of bald area compared to baseline in oral FNS group only.
No significant difference between the two groups in hair thickness, total hair counts and the size of bald area.

Adverse Events:
Erythema of scalp after application of topical FNS (n = 1).
Decreased libido with use of systemic FNS (n= 1).
Rafi and Katz(2011) 3 15 male subjects, age range 24–72 y/o Prospective cohort NuH hair
(topical FNS, dutasteride,
MNX) with the option to add oral FNS, MNX, and/or ketoconazole shampoo for 9 months
Photographs All patients demonstrated significant growth of hair compared to baseline.
In those patients who utilized all 4 components, significant growth compared to baseline was achieved in as little as 30 days.
In those patients who chose to apply NuH Hair only, significant growth compared to baseline was demonstrated after 3 months.

Adverse Events:
No report of contact or irritant dermatitis were reported with the use of NuH Hair.
Tanglertsampan (2012) 2 33 male subjects, age range 27–49 y/o RCT Topical MNX 3% alone vs. MNX 3% + FNS 0.1% (MFX) for 24 weeks Hair count
Photographs
Hair count increased in both groups, but was only significantly improved from baseline in the MFX group.
MFX showed significantly higher efficacy by global photographic assessment compared to MNX.

Adverse Events:
Contact dermatitis experienced in MNX group n = 6 (38%), MFX group n = 4 (24%).
Caserini et al. (2014) 2 23 male subjects, age range 18–65 y/o RCT Topical FNS 0.25% twice daily vs. oral FNS 1 mg once daily for 7 days DHT and testosterone levels in plasma Plasma DHT was reduced by 68–75% with use of topical FNS and by 62–72% with systemic administration.
No relevant changes occurred for plasma testosterone with either treatment.

Adverse Events:
No clinically significant adverse events occurred.
Caserini et al.
(2015)
2 50 male subjects, age range 18–65 y/o RCT Study 1:
1 mL topical FNS 0.25% daily vs. 1 mL topical FNS 0.25% twice daily vs. oral FNS 1 mg daily for 7 days

Study 2:
Placebo vs topical FNS 0.25% twice daily in varying quantities 100 μl vs. 200 μl vs. 300 μl vs. 400 μl for 7 days
DHT concentration in scalp and plasma Testosterone levels in plasma
FNS levels in plasma
Study 1:
70% decrease from baseline in scalp DHT after application of 1 mL topical FNS daily compared to 50% decrease from baseline for both 1 mL topical FNS twice daily or oral FNS.

Study 2:
Scalp DHT reduction was decreased by 47–52% using 100 μl and 200 μl of topical FNS, which was similar to the 37% and 54% reduction seen with 300 μl and 400 μl respectively.
Serum DHT was reduced by 24%, 26%, 44%, and 48% by 100 μl, 200 μl, 300 μl, and 400 μl respectively.
No significant changed occurred in serum testosterone levels.

Adverse Events:
Study 1: Increased alanine aminotransferase, pollakiuria and testicular pain (n = 2, 11.1%)
Study 2: Presyncope, conjunctivitis, headache, oropharyngeal pain (n = 5, 15.6%)
Chandrashekar et al. (2017) 3 50 male subjects, age range 20–40 y/o Retrospec-tive assessment and Prospective cross-over cohort Topical MNX 5% and oral FNS 1 mg for 2 years, followed by either topical MNX 5% + FNS 0.1% (MFX) for 1 year either immediately or after 8–12 months without treatment Photographs 45 subjects underwent continuous treatment with MNX and oral FNS for 2 years and then treatment was continued with MFX.
  –Of these patients, 84.4% maintained good hair density while on MFX.
5 subjects underwent continuous treatment with MNX and oral FNS for 2 years, were discontinued from all treatments for 8–12 months, and then treatment was continued with MFX.
  –Of these patients 80% maintained good hair density while on MFX.

Adverse Events:
No adverse events were reported with either treatment.
Patient compliance was good with topical finasteride.