Phase 3 N=917 Randomized Quadruple-blind Treatment

Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia

Androgenetic Alopecia

Bottom Line

View on ClinicalTrials.gov: NCT01231607 ↗

Enrolled (actual)

917

Serious AEs

0.9%

Results posted

Oct 2012

Primary outcome: Primary: Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT) — -4.9; 17.1; 63.0; 89.6 Hair count — p=0.046

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 1mg Finasteride active (Drug); 0.02mg dutasteride (Drug); 0.1mg dutasteride (Drug); 0.5mg dutasteride (Drug); Finasteride placebo (Drug); Dutasteride placebo (Drug)
Age: Adult · 20+ yrs
Sex: Male
Sponsor: GlaxoSmithKline
Primary completion: Feb 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline (BL) in Target Area Hair Count (HC) Within a 2.54 Centimeter (cm) (1 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by Macrophotographic Technique (MT)	-4.9; 17.1; 63.0; 89.6; 56.5	0.046 sig
SECONDARY Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 24, as Assessed by MT	-0.3; 4.2; 12.4; 18.1; 12.1	—
SECONDARY Change From Baseline in Target Area Hair Count Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 as Assessed by MT	-4.0; 22.9; 59.6; 82.3; 50.9	—
SECONDARY Change From Baseline in Target Area Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex, as Assessed by MT at Week 12	-0.4; 5.1; 12.8; 17.1; 10.8	—
SECONDARY Change From Baseline in Target Area Hair Width Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT	-0.7; 0.3; 3.1; 4.7; 3.2; -0.9	—
SECONDARY Change From Baseline in Target Area Hair Width Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT	-0.1; 0.1; 0.7; 0.9; 0.6; -0.2	—
SECONDARY Change From Baseline in Terminal Hair Count (THC) Within a 2.54 cm (1 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT	-11.5; -13.4; 18.3; 29.3; 24.2; -17.5	—
SECONDARY Change From Baseline in Terminal Hair Count Within a 1.13 cm (0.44 Inch) Diameter Circle at the Vertex at Week 12 and Week 24, as Assessed by MT	-1.1; -2.7; 4.0; 5.9; 4.5; -3.0	—
SECONDARY Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately	-0.15; -0.09; 0.42; 0.63; 0.49; -0.14	—
SECONDARY Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 12 for Vertex and Frontal Views Separately	0.48; 0.35; 0.62; 0.78; 0.70; 0.30	—
SECONDARY Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 24 for Vertex and Frontal Views Separately	0.36; 0.37; 1.03; 1.30; 1.07; 0.30	—
SECONDARY Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 12 (W12)	1; 1; 0; 1; 0; 0	—
SECONDARY Number of Participants With the Indicated Change From Baseline (BL) in the Stage (S) of Androgenic Alopecia (AGA) According to the Norwood-Hamilton Scale at Week 24	3; 2; 2; 3; 2; 0	—
SECONDARY Serum Concentration of Dutasteride at Week 12, Week 24, and Follow-up (Week 26)	0.2; 2.1; 33.2; 0.0; 2.0; 36.1	—
SECONDARY Serum Dihydrotestosterone (DHT) at Week 12, Week 24, and Follow-up (Week 26)	1.17; 0.88; 0.39; 0.31; 0.45; 1.16	—
SECONDARY Change From Baseline in Hair Growth Index (HGI) Scores at Weeks 12 and 24	1.2; 0.9; 1.7; 2.0; 1.7; 1.1	—
SECONDARY Change From Baseline in Total Hair Growth Satisfaction Scale (HGSS) Scores at Weeks 12 and 24	8.5; 7.9; 9.8; 8.4; 8.5; 9.3	—

Summary

The purpose of this six month study is to show that dutasteride is safe and more effective than placebo, and at least as safe and effective as finasteride in treating hair loss in men with androgenetic alopecia. Three doses of dutasteride will be investigated.

Eligibility Criteria

Inclusion Criteria

Norwood-Hamilton Type III vertex, IV, or V

Exclusion Criteria

History or evidence of hair loss other than androgenetic alopecia
Scarring of the scalp
Use of dutasteride in previous 18 months
Use of finasteride within previous 12 months
Hair transplantation or hair weaving within 6 months
Use of Minoxidil within previous 6 months
Use of drugs with anti-androgenetic/androgenetic properties within previous 6 months
Use of Drugs that cause hypertrichosis or hypotrichosis within previous 6 months
Light or laser treatment of scalp within previous 3 months
Cosmetic products aimed at improving or correcting signs of hair loss within previous 2 weeks

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01231607). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.