Back to resultsA Phase 3 Clinical Study Patients With Androgenetic Alopecia (AGA)
Primary Purpose
AGA
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
CU-40102 Spray
Sponsored by
About this trial
This is an interventional treatment trial for AGA
Eligibility Criteria
Inclusion Criteria:
- Having voluntarily signed the ICF approved by the Ethics Committee and consented to participate in this study before starting any study procedure;
- Being able to understand and comply with the requirements of the protocol and agreeing to participate in all study visits;
- Males aged 18 to 41 years (inclusive);
- 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);
- 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:
- A history of scalp skin abnormalities or scalp skin diseases at the time of screening
- Patients with secondary alopecia such as those associated with malnutrition, drugs, endocrine , iron deficiency anemia, or systemic lupus erythematosus;
- Patients with alopecia areata, alopecia cicatrisata, or trichotillomania;
- Having undergone hair transplantation or extension before screening, or persistent requirement to wear a wig sheath during study treatments;
- Known allergy to the active ingredient of the investigational drug or any component of the excipients, or to any component of the tattoo liquid;
- A history of depression, anxiety, personality disorder or other mental disorders;
- A history of varicocele or infertility ;
- A history of malignant tumor;
Sites / Locations
- Peking University People Hosptial
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CU-40102 Spray
Placebo for CU-40102 Spray
Arm Description
0.25% (2.275mg/mL) Finasteride
Placebo Spray
Outcomes
Primary Outcome Measures
The Rate of TAHC
the change from baseline in target area hair count (TAHC) in the vertex after treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT05135468
First Posted
November 16, 2021
Last Updated
July 31, 2023
Sponsor
Cutia Therapeutics（Wuxi）Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05135468
Brief Title
A Phase 3 Clinical Study Patients With Androgenetic Alopecia (AGA)
Official Title
A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Finasteride Spray (CU-40102) in Chinese Adult Male Patients With Androgenetic Alopecia (AGA)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 6, 2021 (Actual)
Primary Completion Date
March 7, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cutia Therapeutics（Wuxi）Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A Multicenter, Randomized, Double-Blind, and Placebo-Controlled Phase 3 Clinical Study ,the mean change from baseline in vertex target area hair count (TAHC) after treatment for 24 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AGA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Drug:0.25% (2.275mg/mL) Finasteride Spray Placebo for CU-40102 Spray
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CU-40102 Spray
Arm Type
Experimental
Arm Description
0.25% (2.275mg/mL) Finasteride
Arm Title
Placebo for CU-40102 Spray
Arm Type
Placebo Comparator
Arm Description
Placebo Spray
Intervention Type
Drug
Intervention Name(s)
CU-40102 Spray
Intervention Description
topical application, 1~4 sprays each time, once daily
Primary Outcome Measure Information:
Title
The Rate of TAHC
Description
the change from baseline in target area hair count (TAHC) in the vertex after treatment
Time Frame
24 weeks.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Having voluntarily signed the ICF approved by the Ethics Committee and consented to participate in this study before starting any study procedure;
Being able to understand and comply with the requirements of the protocol and agreeing to participate in all study visits;
Males aged 18 to 41 years (inclusive);
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);
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:
A history of scalp skin abnormalities or scalp skin diseases at the time of screening
Patients with secondary alopecia such as those associated with malnutrition, drugs, endocrine , iron deficiency anemia, or systemic lupus erythematosus;
Patients with alopecia areata, alopecia cicatrisata, or trichotillomania;
Having undergone hair transplantation or extension before screening, or persistent requirement to wear a wig sheath during study treatments;
Known allergy to the active ingredient of the investigational drug or any component of the excipients, or to any component of the tattoo liquid;
A history of depression, anxiety, personality disorder or other mental disorders;
A history of varicocele or infertility ;
A history of malignant tumor;
Facility Information:
Facility Name
Peking University People Hosptial
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Phase 3 Clinical Study Patients With Androgenetic Alopecia (AGA)
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