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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05135468
Recruitment Status : Active, not recruiting
First Posted : November 26, 2021
Last Update Posted : August 10, 2022
Sponsor:
Information provided by (Responsible Party):
Cutia Therapeutics(Wuxi)Co.,Ltd

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.

Condition or disease Intervention/treatment Phase
AGA Drug: CU-40102 Spray Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Drug:0.25% (2.275mg/mL) Finasteride Spray Placebo for CU-40102 Spray
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : December 6, 2021
Estimated Primary Completion Date : March 30, 2023
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CU-40102 Spray
0.25% (2.275mg/mL) Finasteride
Drug: CU-40102 Spray
topical application, 1~4 sprays each time, once daily

Placebo Comparator: Placebo for CU-40102 Spray
Placebo Spray
Drug: CU-40102 Spray
topical application, 1~4 sprays each time, once daily




Primary Outcome Measures :
  1. The Rate of TAHC [ Time Frame: 24 weeks. ]
    the change from baseline in target area hair count (TAHC) in the vertex after treatment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05135468


Locations
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China, Beijing
Peking University People Hosptial
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Cutia Therapeutics(Wuxi)Co.,Ltd
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Responsible Party: Cutia Therapeutics(Wuxi)Co.,Ltd
ClinicalTrials.gov Identifier: NCT05135468    
Other Study ID Numbers: CU-40102-303
First Posted: November 26, 2021    Key Record Dates
Last Update Posted: August 10, 2022
Last Verified: August 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alopecia
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical