Last updated: 10/17/2022 10:10:04
Medical Chart Review Study to Assess the Effectiveness and Safety of Dutasteride versus Finasteride in a Real World Clinical Setting in Patients with Androgenic Alopecia in South Korea
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Medical Chart Review Study to Assess the Effectiveness and Safety of Dutasteride versus Finasteride in a Real World Clinical Setting in Patients with Androgenic Alopecia in South Korea
Trial description: AGA is an androgen dependent, progressive hair loss condition in genetically predisposed men, usually with family history of hair loss. Topical minoxidil and finasteride have been recommended for treatment of mild to moderate hair loss. Recently, dutasteride was also approved for AGA in South Korea. However, long-term, real-world evidence of the efficacy and safety of dutasteride as compared to finasteride for the treatment of AGA is limited. This study aims to address this gap and to provide real-world evidence of the effectiveness and safety of dutasteride versus finasteride in clinical treatment of AGA over chronic use. This retrospective medical chart review study will span from January 2010 to December 2016 and will be conducted in three phases including a feasibility survey, a pilot study, and a full study. Feasibility survey and pilot study will be carried out to assess the availability and quality of data necessary to complete the full study from medical charts in South Korea. Approximately 1,400 subject charts will be included in the full analysis, of which a subset of 400 will be used to collect data for the effectiveness objective, in a 1:1 ratio of subjects prescribed dutasteride and finasteride.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Assessment of demographic of subjects with AGA
Timeframe: Up to 6 months
Assessment of clinical characteristics of subjects with AGA
Timeframe: Up to 6 months
Assessment of the treatment patterns of subjects with AGA receiving dutasteride or finasteride
Timeframe: Up to 7 years
Change from Baseline in total hair count as a measure of effectiveness of AGA treatments
Timeframe: Baseline and Up to 7 years
Modified global photographic assessment as a measure of effectiveness of AGA treatments
Timeframe: Up to 7 years
The basic and specific (BASP) classification of AGA
Timeframe: Up to 7 years
The Norwood-Hamilton classification of AGA
Timeframe: Up to 7 years
Subject self-assessment score of effectiveness
Timeframe: Up to 7 years
Number of subjects with adverse events (AEs), AEs of special interest, serious AEs (SAEs) and SAEs of special interest
Timeframe: Up to 7 years
Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
1400
Primary completion date:
2020-30-11
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
G.Seong Choi, W.Y. Sim, H. Kang, C. HunHuh, Y. Won Lee, S. Shantakumar, Y.F. Ho, EJ. Oh, M. S. Duh, W. Cheng, P. J. Bobbili, P. Thompson-Leduc, G. Ong. Long-Term Effectiveness and Safety of Dutasteride Versus Finasteride in Patients with Male Androgenic Alopecia in South Korea: A Multicentre Chart Review Study. Ann Dermatol. 2022;34(5):349-359
DOI: https://doi.org/10.5021/ad.22.027
PMID: 36198626
Medical condition
Alopecia
Product
dutasteride, finasteride
Collaborators
Analysis Group
Study date(s)
July 2019 to November 2020
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Male
Age
18+ years
Accepts healthy volunteers
None
- Male subjects.
- At least one confirmed diagnosis of AGA in the subject’s medical chart.
- Any prescription for minoxidil, finasteride, dutasteride, or other AGA therapy during the Baseline period (6 months prior to the index date).
- Prior surgical correction of scalp hair loss.
Inclusion and exclusion criteria
Inclusion criteria:
- Male subjects.
- At least one confirmed diagnosis of AGA in the subject’s medical chart.
- Age >=18 years at date of most recent diagnosis with AGA.
- At least one prescription for dutasteride or finasteride within 6 months of a documented AGA diagnosis in the subject’s medical chart (first prescription for dutasteride or finasteride following a confirmed AGA diagnosis will be defined as the index date).
- At least 6 months of continuous prescription of either dutasteride or finasteride following the index date, as identified by prescription of dutasteride for at least 6 months post the index date in the subject’s medical chart.
Exclusion criteria:
- Any prescription for minoxidil, finasteride, dutasteride, or other AGA therapy during the Baseline period (6 months prior to the index date).
- Prior surgical correction of scalp hair loss.
- Liver disease (chronic stable hepatitis B and C are acceptable if the subject otherwise meets eligibility criteria).
- History of malignancy, except non-melanotic cancers of the skin (unless affecting the scalp).
- Presence of global hair thinning, scarring of the scalp, hair loss not caused by AGA, or any other disease or condition of the scalp or hair.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2020-30-11
Actual study completion date
2020-30-11
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website