Zagallo Capsules Drug Use Investigation (202029)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational post-marketing surveillance

Study drug and medical condition

• Name of medicine, other:
  zagallo capsules
• Medical condition to be studied:
  Androgenetic alopecia

Population studied

• Short description of the study population:
  Male patients aged 18 years or older diagnosed with androgenetic alopecia (AGA) receiving Zagallo for the first time for hair growth, hair restoration and prevention of hair loss under routine clinical practice from May 2016 to January 2019.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Other

  Renal impaired
• Special population of interest, other:
  Patients with androgenetic alopecia
• Estimated number of subjects:
  4000

Study design details

• Main study objective:
  This investigation is implemented to collect and evaluate the information on safety and effectiveness of Zagallo Capsules in male patients with androgenetic alopecia in daily clinical practice.
• Outcomes:
  Information regarding the safety and efficacy of Zagallo Capsules under the actual post-marketing use conditions of the product.
• Data analysis plan:
  Patient disposition ADR related itemsResponse rate based on the global assessment of effectivenessFactors considered influential on safety and effectiveness, odds ratio and 95% confidence interval thereof shall be calculated for the factors considered influential.

Documents

Study results

gsk-202029-clinical-study-report-redact