A Phase 3 Clinical Study Patients With Androgenetic Alopecia (AGA)

Launched by CUTIA THERAPEUTICS（WUXI）CO.,LTD · Nov 16, 2021

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Having voluntarily signed the ICF approved by the Ethics Committee and consented to participate in this study before starting any study procedure;
• • 2. Being able to understand and comply with the requirements of the protocol and agreeing to participate in all study visits;
• • 3. Males aged 18 to 41 years (inclusive);
• • 4. Being diagnosed with Type III vertex, Type IV or Type V androgenetic alopecia (AGA) according to the Hamilton-Norwood classification (see Appendix 1 for details);
• • 5. Appropriate medical contraceptive methods being used to prevent the sexual partner from becoming pregnant from the time of signing ICF to 28 days after the last dose; -
• Exclusion Criteria:
• • 1. A history of scalp skin abnormalities or scalp skin diseases at the time of screening
• • 2. Patients with secondary alopecia such as those associated with malnutrition, drugs, endocrine , iron deficiency anemia, or systemic lupus erythematosus;
• • 3. Patients with alopecia areata, alopecia cicatrisata, or trichotillomania;
• • 4. Having undergone hair transplantation or extension before screening, or persistent requirement to wear a wig sheath during study treatments;
• • 5. Known allergy to the active ingredient of the investigational drug or any component of the excipients, or to any component of the tattoo liquid;
• • 6. A history of depression, anxiety, personality disorder or other mental disorders;
• • 7. A history of varicocele or infertility ;
• • 8. A history of malignant tumor;