A Long-term Study to Determine Safety and Efficacy of Dutasteride in Male Subjects With Androgenetic Alopecia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01831791
First received: April 11, 2013
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

This is a multicentre, open-label study to assess the safety, tolerability, and efficacy of 0.5 mg Dutasteride administered once daily for 52 weeks in men with Androgenetic Alopecia types III vertex, IV and V per the Norwood-Hamilton classification. The study consists of a Screening Phase (3 weeks prior to Baseline) and a Treatment Phase (52 weeks). A subject who completes the full course of study treatment and the final study visit (Week 52; Visit 7) will be considered as study completion.


Condition Intervention Phase
Alopecia
Drug: Dutasteride 0.5 mg
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study ARI114264: A Long-Term Study of the Safety and Efficacy of Dutasteride in the Treatment of Male Subjects With Androgenetic Alopecia

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Assessment of AEs, and PSRAEs [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
    AE (adverse event) is defined as any untoward medical occurrence in a subject or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Possible suicidality-related AE (PSRAE) is possibly related to suicidality as per Investigator's judgement.

  • Incidence of drug-related, treatment-emergent AEs [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
  • Incidence of premature discontinuations [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
    The number and percentage of premature discontinuations will be assessed at 26 weeks and 52 weeks

  • Incidence of SAEs [ Time Frame: Up to 55 weeks ] [ Designated as safety issue: No ]
    An SAE (serious adverse event) is defined as any untoward medical occurrence that, at any dose: Results in death; is life threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; or is a congenital anomaly/birth defect; all events of possible drug-induced liver injury with hyperbilirubinaemia; breast cancer in male subject; prostate cancer; spontaneous abortion in female partner of male subject.

  • Incidence of abnormal laboratory tests [ Time Frame: Up to 55 weeks ] [ Designated as safety issue: No ]
    Clinical laboratory parameters including hematology, clinical chemistry and prostate-specific antigen (PSA) will be assessed at Screening, 26 weeks, and 52 weeks

  • Change from Baseline vital signs and clinical laboratory measurements to assess safety [ Time Frame: Screening and up to 55 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in vital signs for heart rate and systolic and diastolic blood pressure and change from Baseline in clinical laboratory for hematology, chemistry and PSA at Screening, 26 weeks, and 52 weeks will be assessed

  • Change from Baseline in breast examination findings [ Time Frame: Screening and up to 55 weeks ] [ Designated as safety issue: No ]
    Changes from Baseline in breast examination (such as breast enlargement and breast tenderness, a mass, or any signs suggestive of malignancy) at Screening, 26 weeks, and 52 weeks will be assessed

  • Assessment of suicidality using C SSRS [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
    Suicidality will be assessed at Baseline, 26 weeks, and 52 weeks using Columbia Suicide-Severity Rating Scale (C SSRS).


Secondary Outcome Measures:
  • Change from Baseline in target area and terminal area hair count to assess hair growth and restoration at 26 weeks [ Time Frame: Baseline and up to 26 weeks ] [ Designated as safety issue: No ]
    Change from Baseline in target area and terminal area hair count within a 2.54-centimeter (cm) (1-inch) diameter circle at the vertex will be measured at Baseline, 26 weeks and 52 weeks, using macrophotographic technique. The target area and terminal area count will include nonvellus hair of >=30 micrometer (mcm) and terminal hair of >=60 mcm respectively using each macrophotograph.

  • Change from Baseline in target area and terminal area hair count to assess hair growth and restoration at 52 weeks [ Time Frame: Baseline and up to 52 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in target area hair width to assess hair restoration at 26 weeks. [ Time Frame: Baseline and up to 26 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in target area hair width to assess hair restoration at 52 weeks. [ Time Frame: Baseline and up to 52 weeks ] [ Designated as safety issue: No ]
  • Global assessment of improvement from baseline to 26 weeks [ Time Frame: Baseline and up to 26 weeks ] [ Designated as safety issue: No ]
    Panel global assessment of improvement will be measured to assess change in hair growth at Baseline, 26 weeks and 52 weeks using 7 point scale (1=greatly decreased, 7=greatly increased). The global photographs of the vertex and frontal views obtained at Baseline will be compared with 26 weeks and 52 weeks photographs.

  • Global assessment of improvement from baseline to 52 weeks [ Time Frame: Baseline and up to 52 weeks ] [ Designated as safety issue: No ]
  • Change in stage of AGA according to the Norwood-Hamilton scale at 26 weeks [ Time Frame: Screening and Week 26 ] [ Designated as safety issue: No ]
    Investigator assessments includes change in stage of androgenetic alopecia (AGA) at Screening, 26 weeks and 52 weeks according to the Norwood-Hamilton classification

  • Change in stage of AGA according to the Norwood-Hamilton scale at 52 weeks [ Time Frame: Screening and Week 55 ] [ Designated as safety issue: No ]
  • Change from Baseline in sexual problems assessed by PAS SFI [ Time Frame: Baseline and Up to 52 weeks ] [ Designated as safety issue: No ]
    Change in sexual functions will be assessed at Baseline, 13 weeks, 26 weeks, 39 weeks, and 52 weeks using Problem Assessment Scale of the Sexual Function Inventory (PAS SFI). Three questions are scored in a 5 point scale of 0 to 4 (0=big problem, 4=no problem). Total scores range from 0-12.

  • Change from Baseline in quality of life assessed by DLQI [ Time Frame: Baseline and up to 52 weeks ] [ Designated as safety issue: No ]
    Change in quality of life will be assessed at Baseline, 13 weeks, 26 weeks, 39 weeks, and 52 weeks using Dermatology Life Quality Index (DLQI). Ten items are scored in a 4 point scale (0=very much, 3=not at all). Total scores range from 0-30

  • Measurement of serum DHT concentrations [ Time Frame: Up to 55 weeks ] [ Designated as safety issue: No ]
    Blood samples for dihydrotestosterone (DHT) concentration will be collected at Screening, 26 weeks and 52 weeks


Enrollment: 120
Study Start Date: April 2013
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dutasteride Arm
Subjects will receive 1 capsule of Dutasteride 0.5 mg orally once daily for 52 weeks (12 months).
Drug: Dutasteride 0.5 mg
Dutasteride will be supplied as soft gelatin capsules, containing 0.5 mg of Dutasteride and it will be packaged in high-density polyethylene (HDPE) bottles with plastic child-resistant closures.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male outpatient, 20 to 50-years-old, inclusive (at the time of obtaining consent).
  • AGA classified as Type III vertex, IV, or V (excluding Type IV anterior and V anterior) utilizing the Norwood-Hamilton classification.
  • Fluent and literate in Japanese with the ability to comprehend and record information on the PAS SFI and DLQI questionnaires.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2 x upper limit of normal (ULN); alkaline phosphatase and bilirubin <=1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%).
  • Willing to comply with study requirements, including maintaining the same hair color and hairstyle throughout the study- a) subjects who use hair colorants/hair dyes may continue to do so; however, there should be no traces of hair color remaining on the scalp at the time of study visits. b) hair length in nonbalding areas should be >=2 cm (0.75 inch) around the vertex region of the head at the time of study visits.
  • Able to swallow and retain oral medication

Exclusion Criteria:

  • Evidence of hypogonadism defined as serum testosterone <250 Nanogram/decilitre (ng/dl) at Screening.
  • Unstable liver disease (chronic stable hepatitis B and C are acceptable if subject otherwise meets entry criteria).
  • History of renal insufficiency or Serum creatinine >1.5 x ULN at Screening.
  • History of malignancy within the past 5 years, except basal cell or squamous cell carcinoma of the skin.
  • History of prostate cancer before the age of 50 years in a first degree relative.
  • Serum PSA level >2.0 nanogram/millilitre (ng/mL) at Screening.
  • History of breast cancer or clinical breast examination suggestive of malignancy.
  • Active unstable thyroid disease, including subjects on therapy for either hyperthyroidism or hypothyroidism unless their dose of thyroid medication has been stable for at least 3 months.
  • Any unstable, serious co-existing medical condition(s) including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to Screening; uncontrolled diabetes or peptic ulcer disease which is uncontrolled by medical management, and subjects who are known to be acquired immunodeficiency syndrome [AIDS](including subjects with a diagnosis of human immunodeficiency virus (HIV) positive).
  • History or current evidence of any serious and/or unstable pre-existing medical or psychiatric disorder, or other conditions that could, in the opinion of the investigator or GSK medical monitor, interfere with the subject's safety, obtaining informed consent, or compliance with study procedures. Note: the investigator may consult with GSK medical monitor if a condition could interfere with the subject's safety.
  • Clinically relevant abnormal finding on the Screening electrocardiogram (ECG).
  • Global scalp hair thinning, including occipital areas.
  • Scarring of the scalp, including prior hair transplant or scalp reduction, or any other condition or disease of the scalp or hair, including diseases of the hair shaft (e.g., tinea infection, nonandrogenetic-cause of alopecia, psoriatic dermatitis or other psoriatic lesions, or uncontrolled seborrheic dermatitis).
  • History of hair transplantation at any time to correct AGA or use of hair weaving within 6 months prior to Screening.
  • History or evidence of hair loss other than AGA (e.g., due to an auto-immune, endocrine, mechanical or infectious process, or secondary to a scalp dermatological disorder).
  • Use of any cosmetic product aimed at improving or correcting the signs of hair loss (e.g., scalp preparations with claims aiming at improved hair growth) within 2 weeks prior to Screening.
  • Use of light or laser treatments on the scalp (e.g., light emitting diode [LED] lamps) within 3 months prior to Screening.
  • Hypersensitivity to any 5 alpha-reductase (5AR) inhibitor or drugs chemically related to the study treatment.
  • Use of Dutasteride within 18 months prior to Screening, or use of finasteride within 12 months prior to Screening.
  • Previous use of systemic cytotoxic agents.
  • Use of glucocorticoids (inhaled glucocorticoids are allowed; topical corticosteroids are allowed provided that they are not used on the scalp) within 3 months prior to Screening.
  • Use of the following during the 6 months prior to Screening: Minoxidil (oral or topical), Carpronium chloride, Systemic drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone, ketoconazole, flutamide, and bicalutamide). Use of ketoconazole shampoo on the scalp is prohibited during the study, but use before Screening is not a reason for exclusion. Cimetidine is prohibited during the study, but use before Screening is not a reason for exclusion, Topical estrogen or progesterone, Topical prostaglandin analogs on the scalp, Tamoxifen, Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin, psoralens), Drugs potentially causing hypotrichosis or telogen effluvium (e.g., valproic acid), Anabolic steroids, Lithium or phenothiazines.
  • Participation in any investigational or marketed drug or device trial within 1 month prior to Screening for this study. Including participation in any trial for Dutasteride and administration of active drugs (Dutasteride or finasteride) prior to Screening for this study. In addition, subjects must not participate in any other drug or device trials during the course of this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01831791

Locations
Japan
GSK Investigational Site
Fukuoka, Japan, 812-0025
GSK Investigational Site
Osaka, Japan, 532-0003
GSK Investigational Site
Osaka, Japan, 530-0057
GSK Investigational Site
Tokyo, Japan, 160-0022
GSK Investigational Site
Tokyo, Japan, 103-0028
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01831791     History of Changes
Other Study ID Numbers: 114264
Study First Received: April 11, 2013
Last Updated: August 21, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceutical and Medical Device Agency

Keywords provided by GlaxoSmithKline:
male pattern hair loss
hair growth
hair restoration
Dutasteride
Androgenetic alopecia
safety
efficacy

Additional relevant MeSH terms:
Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical
Dutasteride
5-alpha Reductase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014