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Trial record 28 of 103 for:    "androgenetic alopecia" OR "female pattern baldness" OR "male pattern baldness"

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

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Androgenetic Alopecia
Interventions: Drug: 1mg Finasteride active
Drug: 0.02mg dutasteride
Drug: 0.1mg dutasteride
Drug: 0.5mg dutasteride
Drug: Finasteride placebo
Drug: Dutasteride placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dutasteride 0.02 mg Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
Dutasteride 0.1 mg Dutasteride 0.1 mg and finasteride placebo once daily
Dutasteride 0.5 mg Dutasteride 0.5 mg and finasteride placebo once daily
Finasteride 1 mg Finasteride 1 mg and dutasteride placebo once daily
Placebo Matching dutasteride placebo and finasteride placebo once daily

Participant Flow:   Overall Study
    Dutasteride 0.02 mg   Dutasteride 0.1 mg   Dutasteride 0.5 mg   Finasteride 1 mg   Placebo
STARTED   185   188   184   179   181 
COMPLETED   156   154   153   141   157 
NOT COMPLETED   29   34   31   38   24 
Adverse Event                0                8                4                4                5 
Lost to Follow-up                13                11                10                10                4 
Physician Decision                4                4                3                5                4 
Protocol Violation                3                2                0                2                2 
Withdrawal by Subject                9                9                14                17                9 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dutasteride 0.02 mg Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
Dutasteride 0.1 mg Dutasteride 0.1 mg and finasteride placebo once daily
Dutasteride 0.5 mg Dutasteride 0.5 mg and finasteride placebo once daily
Finasteride 1 mg Finasteride 1 mg and dutasteride placebo once daily
Placebo Matching dutasteride placebo and finasteride placebo once daily
Total Total of all reporting groups

Baseline Measures
   Dutasteride 0.02 mg   Dutasteride 0.1 mg   Dutasteride 0.5 mg   Finasteride 1 mg   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 185   188   184   179   181   917 
Age 
[Units: Years]
Mean (Standard Deviation)
 38.5  (7.72)   38.7  (7.44)   38.6  (7.66)   38.0  (7.81)   38.7  (8.43)   38.5  (7.80) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
           
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      185 100.0%      188 100.0%      184 100.0%      179 100.0%      181 100.0%      917 100.0% 
Race/Ethnicity, Customized 
[Units: Participants]
           
Asian - Japanese Heritage   40   40   40   40   39   199 
American Indian or Alaskan Native   37   38   39   36   38   188 
African American/African Heritage   1   0   0   0   1   2 
Asian - South East Asian Heritage   44   43   42   41   41   211 
Asian - East Asian Heritage   19   20   19   19   19   96 
Asian - Mixed Race   0   0   0   0   1   1 
White - White/Caucasian/European Heritage   44   47   44   43   42   220 


  Outcome Measures

1.  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)   [ Time Frame: Baseline and Week 24 ]

2.  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   [ Time Frame: Baseline and Week 24 ]

3.  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   [ Time Frame: Baseline and Week 12 ]

4.  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   [ Time Frame: Baseline and Week 12 ]

5.  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   [ Time Frame: Baseline, Week 12, and Week 24 ]

6.  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   [ Time Frame: Baseline, Week 12, and Week 24 ]

7.  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   [ Time Frame: Baseline, Week 12, and Week 24 ]

8.  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   [ Time Frame: Baseline, Week 12, and Week 24 ]

9.  Secondary:   Global Assessment of Improvement From Baseline to Week 24 Assessed for Vertex and Frontal Views Separately   [ Time Frame: Baseline and Week 24 ]

10.  Secondary:   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 ]

11.  Secondary:   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 ]

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 12 (W12)   [ Time Frame: Baseline and Week 12 ]

13.  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   [ Time Frame: Baseline and Week 24 ]

14.  Secondary:   Serum Concentration of Dutasteride at Week 12, Week 24, and Follow-up (Week 26)   [ Time Frame: Week 12, Week 24, and Week 26 ]

15.  Secondary:   Serum Dihydrotestosterone (DHT) at Week 12, Week 24, and Follow-up (Week 26)   [ Time Frame: Week 12, Week 24, and Week 26 ]

16.  Secondary:   Change From Baseline in Hair Growth Index (HGI) Scores at Weeks 12 and 24   [ Time Frame: Baseline, Week 12, and Week 24 ]

17.  Secondary:   Change From Baseline in Total Hair Growth Satisfaction Scale (HGSS) Scores at Weeks 12 and 24   [ Time Frame: Baseline, Week 12, and Week 24 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01231607     History of Changes
Other Study ID Numbers: 114263
First Submitted: October 28, 2010
First Posted: November 1, 2010
Results First Submitted: August 30, 2012
Results First Posted: October 4, 2012
Last Update Posted: August 10, 2018