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Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia

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ClinicalTrials.gov Identifier: NCT01231607
Recruitment Status : Completed
First Posted : November 1, 2010
Results First Posted : October 4, 2012
Last Update Posted : August 10, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE October 28, 2010
First Posted Date  ICMJE November 1, 2010
Results First Submitted Date  ICMJE August 30, 2012
Results First Posted Date  ICMJE October 4, 2012
Last Update Posted Date August 10, 2018
Study Start Date  ICMJE October 28, 2010
Actual Primary Completion Date February 1, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2012)
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) [ Time Frame: Baseline and Week 24 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
target area hair count [ Time Frame: 24 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2012)
  • 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 [ Time Frame: Baseline and Week 24 ]
    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.
  • 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 [ Time Frame: Baseline and 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 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.
  • 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 [ Time Frame: Baseline and 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.
  • 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 [ Time Frame: Baseline, Week 12, and Week 24 ]
    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.
  • 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 [ Time Frame: Baseline, Week 12, and Week 24 ]
    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.
  • 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 [ Time Frame: Baseline, Week 12, and Week 24 ]
    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.
  • 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 [ Time Frame: Baseline, Week 12, and Week 24 ]
    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.
  • Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately [ Time Frame: Baseline and Week 24 ]
    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.
  • Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 12 for Vertex and Frontal Views Separately [ Time Frame: Baseline and Week 12 ]
    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.
  • Change From Baseline in Investigator Photographic Assessment Questionnaire (IPAQ) Scores Assessed at Week 24 for Vertex and Frontal Views Separately [ Time Frame: Baseline and Week 24 ]
    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.
  • 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) [ Time Frame: Baseline and Week 12 ]
    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.
  • 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 [ Time Frame: Baseline and 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.
  • Serum Concentration of Dutasteride at Week 12, Week 24, and Follow-up (Week 26) [ Time Frame: Week 12, Week 24, and 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).
  • Serum Dihydrotestosterone (DHT) at Week 12, Week 24, and Follow-up (Week 26) [ Time Frame: Week 12, Week 24, and 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).
  • Change From Baseline in Hair Growth Index (HGI) Scores at Weeks 12 and 24 [ Time Frame: Baseline, Week 12, and Week 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).
  • Change From Baseline in Total Hair Growth Satisfaction Scale (HGSS) Scores at Weeks 12 and 24 [ Time Frame: Baseline, Week 12, and Week 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: October 28, 2010)
  • Target area hair width [ Time Frame: 12 and 24 weeks ]
  • Terminal hair count [ Time Frame: 12 and 24 weeks ]
  • Target area hair count [ Time Frame: 12 weeks ]
  • Global panel assessment of improvement from baseline [ Time Frame: 24 weeks ]
  • Investigator photographic assessment questionnaire [ Time Frame: 12 and 24 weeks ]
  • Change in AGA stage [ Time Frame: 12 and 24 weeks ]
  • PK and DHT concentrations [ Time Frame: 12 and 24 weeks ]
  • Hair Growth Index [ Time Frame: 12 and 24 weeks ]
  • Hair Growth Satisfaction Scale [ Time Frame: 12 and 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia
Official Title  ICMJE 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
Brief 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.
Detailed Description

Androgenetic alopecia is a common, androgen-induced, pattern of progressive loss of scalp hair with an onset at any age after puberty in genetically predisposed people. The influence of androgens on scalp hair growth is mediated by local and systemic conversion of testosterone to dihydrotestosterone , by the enzyme 5 alpha-reductase. 5 alpha-reductase has been shown to exist as 2 isoenzyme forms, Type 1 and Type 2. Type 1 is predominantly located in the skin, both in the hair follicles and sebaceous glands, and is also found in the liver and kidney . Type 2 is the dominant form in male genitalia, including the prostate, although it has also been reported to be present in the inner root sheath of the hair follicle. The presence of both isoenzymes in the hair follicles suggests that both forms are likely to be important in the pathogenesis and treatment of androgenetic alopecia. Inhibition of both Type 1 and Type 2 5 alpha-reductase may be expected to more effectively reduce systemic and local dihydrotestosterone levels than inhibition of either isoenzyme alone.

Finasteride is a selective Type 2 5 alpha-reductase inhibitor that is currently the only approved oral treatment for androgenetic alopecia worldwide. Dutasteride inhibits both Type 1 and Type 2 5alpha-reductase and is approved in more than 80 countries for the treatment of benign prostatic hyperplasia, and in Korea for the treatment of hair loss. Dutasteride is approximately 3 times as potent as finasteride at inhibiting Type 2 5 alpha-reductase and more than 100 times as potent at inhibiting Type 1 5 alpha-reductase.

In a Phase II double-blind, placebo-controlled clinical study (ARIA2004) conducted in the United States, dutasteride demonstrated significant increases in target area hair count, as compared with placebo, as early as 12 weeks. In a Phase III double- blind, placebo-controlled clinical study conducted in Korea, dutasteride 0.5 milligram (mg) demonstrated significant increases in target area hair count, as compared with placebo, at 24 weeks. This 6 month study is being conducted to provide additional evidence of the efficacy and safety of three doses of dutasteride (0.02, 0.1 and 0.5mg) in the treatment of androgenetic alopecia, and more specifically, to characterize the dose-response relationship in an ethnically-diverse population. Treatment arms will be equally balanced with approximately 180 per arm.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Androgenetic Alopecia
Intervention  ICMJE
  • Drug: 1mg Finasteride active
    1mg finasteride active, by mouth once daily
  • Drug: 0.02mg dutasteride
    0.02mg dutasteride active, by mouth once daily
  • Drug: 0.1mg dutasteride
    0.1mg dutasteride active, by mouth once daily
  • Drug: 0.5mg dutasteride
    0.5mg dutasteride active, by mouth once daily
  • Drug: Finasteride placebo
    finasteride placebo, by mouth once daily
  • Drug: Dutasteride placebo
    dutasteride placebo, by mouth once daily
Study Arms  ICMJE
  • Active Comparator: 1mg Finasteride
    1mg finasteride active plus dutasteride placebo, by mouth once daily
    Interventions:
    • Drug: 1mg Finasteride active
    • Drug: Dutasteride placebo
  • Active Comparator: 0.02mg Dutasteride
    0.02mg dutasteride active plus finasteride placebo, by mouth once daily
    Interventions:
    • Drug: 0.02mg dutasteride
    • Drug: Finasteride placebo
  • Active Comparator: 0.1mg Dutasteride
    0.1mg dutasteride active plus finasteride placebo, by mouth once daily
    Interventions:
    • Drug: 0.1mg dutasteride
    • Drug: Finasteride placebo
  • Active Comparator: 0.5mg Dutasteride
    0.5mg dutasteride active plus finasteride placebo, by mouth once daily
    Interventions:
    • Drug: 0.5mg dutasteride
    • Drug: Finasteride placebo
  • Placebo Comparator: Placebo
    1mg finasteride placebo plus dutasteride placebo, by mouth once daily
    Interventions:
    • Drug: Finasteride placebo
    • Drug: Dutasteride placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2013)
917
Original Estimated Enrollment  ICMJE
 (submitted: October 28, 2010)
900
Actual Study Completion Date  ICMJE February 28, 2012
Actual Primary Completion Date February 1, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Chile,   Japan,   Mexico,   Peru,   Philippines,   Russian Federation,   Taiwan,   Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01231607
Other Study ID Numbers  ICMJE 114263
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP