Androgenetic Alopecia Clinical Trial
Official title:
A Study of the Efficacy and Safety of Multiple Doses of Dutasteride Versus Placebo and Finasteride in the Treatment of Male Subjects With Androgenetic Alopecia
Verified date | June 2018 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 917 |
Est. completion date | February 28, 2012 |
Est. primary completion date | February 1, 2012 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 20 Years to 50 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Argentina | GSK Investigational Site | Buenos Aires | |
Argentina | GSK Investigational Site | Buenos Aires | |
Argentina | GSK Investigational Site | Caba | Buenos Aires |
Argentina | GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Buenos Aires |
Argentina | GSK Investigational Site | La Boca | Buenos Aires |
Chile | GSK Investigational Site | Santiago | Región Metro De Santiago |
Chile | GSK Investigational Site | Viña del Mar | Valparaíso |
Japan | GSK Investigational Site | Fukuoka | |
Japan | GSK Investigational Site | Osaka | |
Japan | GSK Investigational Site | Osaka | |
Japan | GSK Investigational Site | Tokyo | |
Japan | GSK Investigational Site | Tokyo | |
Mexico | GSK Investigational Site | Mazatlan, Sinaloa | Sinaloa |
Mexico | GSK Investigational Site | Mexico City | |
Mexico | GSK Investigational Site | Mexico city | |
Mexico | GSK Investigational Site | Monterrey | Nuevo León |
Mexico | GSK Investigational Site | Naucalpan | Estado De México |
Mexico | GSK Investigational Site | Zapopan, Jalisco | Jalisco |
Peru | GSK Investigational Site | Lima | |
Peru | GSK Investigational Site | Lima 41 | Lima |
Peru | GSK Investigational Site | Lima Cercado | |
Philippines | GSK Investigational Site | Makati City | |
Philippines | GSK Investigational Site | Manila | |
Philippines | GSK Investigational Site | Quezon City | |
Philippines | GSK Investigational Site | Quezon City | |
Philippines | GSK Investigational Site | Tanauan City, Batangas | |
Russian Federation | GSK Investigational Site | Moscow, | |
Russian Federation | GSK Investigational Site | Nizhny Novgorod | |
Russian Federation | GSK Investigational Site | Ryazan | |
Russian Federation | GSK Investigational Site | St'Petersburg | |
Russian Federation | GSK Investigational Site | St-Petersburg | |
Taiwan | GSK Investigational Site | Tainan | |
Taiwan | GSK Investigational Site | Taipei | |
Taiwan | GSK Investigational Site | Taipei | |
Taiwan | GSK Investigational Site | Taipei | |
Thailand | GSK Investigational Site | Bangkoknoi Bangkok | |
Thailand | GSK Investigational Site | Chiang Mai | |
Thailand | GSK Investigational Site | Patumwan Bangkok | |
Thailand | GSK Investigational Site | Rajthevee Bangkok |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Argentina, Chile, Japan, Mexico, Peru, Philippines, Russian Federation, Taiwan, Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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) | The primary target area HC was based on the nonvellus hair (>=30 micrometers [µm] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value. | Baseline and Week 24 | |
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 | The primary target area HC was based on the nonvellus hair (>=30 micrometers [µm] in width; thick and noticeable hair) count within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 24 value minus the BL value. | Baseline and Week 24 | |
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 | The primary target area HC was based on the nonvellus hair (>=30 micrometers [µm] in width; thick and noticeable hair) count within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12 value minus the BL value. | Baseline and Week 12 | |
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 | The primary target area HC was based on the nonvellus hair (>=30 micrometers [µm] in width; thick and noticeable hair) count within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12 value minus the BL value. | Baseline and Week 12 | |
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 | The target area hair width was the sum of all nonvellus hairs (>=30 µm in width; thick and noticeable hair) within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). For the MT, hair was clipped before each photograph. A cosmetic ink dot was placed by tattoo at Baseline so that the same area could be identified at Baseline and post-Baseline. If the ink dot faded, it was re-done in exactly the same location to ensure it was visible for subsequent photographs. Change from Baseline was calculated as the Week 12 or Week 24 value minus the Baseline value. | Baseline, Week 12, and Week 24 | |
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 | The target area hair width was the sum of all nonvellus hairs (>=30 µm in width; thick and noticeable hair) within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). For the MT, hair was clipped before each photograph. A cosmetic ink dot was placed by tattoo at Baseline so that the same area could be identified at Baseline and post-Baseline. If the ink dot faded, it was re-done in exactly the same location to ensure it was visible for subsequent photographs. Change from Baseline was calculated as the Week 12 or Week 24 value minus the Baseline value. | Baseline, Week 12, and Week 24 | |
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 | The THC (thick, long, and dark hair) was the sum of all nonvellus hairs (>=60 µm in width; thick and noticeable hair) within a target 2.54 cm (1 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on the hair follicles in the photographs. Change from BL=Week 12/Week 24 value minus BL value. | Baseline, Week 12, and Week 24 | |
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 | The THC (thick, long, and dark hair) was the sum of all nonvellus hairs (>=60 µm in width; thick and noticeable hair) within a target 1.13 cm (0.44 inch) diameter circle at the vertex (crown, topmost part of the head). A cosmetic ink dot was placed by tattoo at BL so that the same area could be identified at BL and post-BL. If the ink dot faded, it was re-done in exactly the same location to ensure visibility for subsequent photographs. For the MT, hair was clipped before each photograph; HC was based on hair follicles in the photographs. Change from BL=Week 12/Week 24 value minus BL value. | Baseline, Week 12, and Week 24 | |
Secondary | Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately | A central panel of 3 dermatologists independently assessed change in hair growth from Baseline to Week 24 using a 7-point scale: greatly decreased (-3), moderately decreased (-2), slightly decreased (-1), no change (0), slightly increased (1), moderately increased (2), and greatly increased (3). The median score, across the 3 panel members, is summarized. This assessment was performed by comparing the global photographs obtained at Baseline with those subsequently obtained at Week 24. This assessment was made separately based on the global photography of the vertex and frontal views. | Baseline and Week 24 | |
Secondary | Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 12 for Vertex and Frontal Views Separately | The IPAQ was completed by the Investigator or designee by comparing the global photographs obtained at Baseline with those obtained at Week 12. This assessment was made separately based on the global photography of the vertex and frontal views. The change from Baseline in hair growth was assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. | Baseline and Week 12 | |
Secondary | Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 24 for Vertex and Frontal Views Separately | The IPAQ was completed by the Investigator or designee by comparing the global photographs obtained at Baseline with those obtained at Week 12. This assessment was made separately based on the global photography of the vertex and frontal views. The change from Baseline in hair growth was assessed using the following 7-point scale: -3 = greatly decreased, -2 = moderately decreased, -1 = slightly decreased, 0 = no change, +1 = slightly increased, +2 = moderately increased, +3 = greatly increased. | Baseline and Week 24 | |
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) | The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Baseline and Week 12 (W12). "v," vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. "a," type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex. | Baseline and Week 12 | |
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 | The investigator/designee assessed the stage (Stage I to Stage VII) of AGA (i.e., male pattern baldness [MPB]) by utilizing the Norwood-Hamilton scale, used to measure the progression of MPB. Stage VII indicates worse balding than stage I. Assessment was made by direct visual examination (aided by pictures) of the participant at Baseline and Week 24 (W24). "v," vertex; most of the hair loss (commonly seen with advancing age) is on the vertex. "a," type a variant; major features are (1) the entire anterior hairline border recedes in unison; (2) there is no simultaneous balding of the vertex. | Baseline and Week 24 | |
Secondary | Serum Concentration of Dutasteride at Week 12, Week 24, and Follow-up (Week 26) | Serum concentrations of dutasteride were measured after 12 weeks and 24 weeks of study treatment and at follow-up (approximately 2 weeks after the last dose of study treatment). | Week 12, Week 24, and Week 26 | |
Secondary | Serum Dihydrotestosterone (DHT) at Week 12, Week 24, and Follow-up (Week 26) | Serum concentrations of DHT were measured after 12 weeks and 24 weeks of study treatment and at follow-up (approximately 2 weeks after the last dose of study treatment). | Week 12, Week 24, and Week 26 | |
Secondary | Change From Baseline in Hair Growth Index (HGI) Scores at Weeks 12 and 24 | Participant-perceived change in HG was assessed by 3 questions (each scored on a 7-point scale) on a health outcome questionnaire: "Since the start of treatment, when I look at my thinning area, I can see...", "Since the start of treatment, my hair now covers…", and "Since the start of treatment, the appearance (thickness/quality/amount) of the thinning area on my head is…" -3, Much less; -2, Moderately less; -1, Slightly less; 0, The same amount; 1, Slightly more; 2, Moderately more; 3, Much more scalp. The scores for the 3 questions were summed to obtain the HGI total score (-9 to 9). | Baseline, Week 12, and Week 24 | |
Secondary | Change From Baseline in Total Hair Growth Satisfaction Scale (HGSS) Scores at Weeks 12 and 24 | Participant satisfaction with hair appearance/growth was assessed by 5 questions (each scored on a 7-point scale: How satisfied do you feel about: [1] The overall appearance of your hair; [2] The appearance of the thinning area[s] [TAs] on your head; [3] The amount of scalp that can be seen in the TAs; [4] The amount of hair in the TAs; [5] The growth of hair in the TAs): -3, Very dissatisfied (DS); -2, DS; -1, Somewhat DS; 0, Neutral (neither satisfied nor DS); 1, Somewhat satisfied (SA); 2, SA; 3, Very SA. The scores for the 5 questions were summed to obtain the HGSS total score (-15 to 15). | Baseline, Week 12, and Week 24 |
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