NCT06409650

Brief Summary

This was a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 Tincture in Chinese adult female subjects with AGA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 9, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 10, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
Last Updated

May 22, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 7, 2024

Last Update Submit

May 20, 2024

Conditions

Alopecia

Keywords

Androgenetic AlopeciaHair lossFemale pattern hair loss

Outcome Measures

Primary Outcomes (1)

  • Assessment of change in Target Area Hair Counts

    Changes from baseline in non-vellus TAHC (Target Area Hair Counts) in comparison to placebo (Non-vellus TAHC is the number of non-vellus hairs within 1 cm² scalp, which usually ranges from 0 to 300. Larger non-vellus TAHC implies thicker hair. In this study, larger change in non-vellus TAHC means better outcome.)

    24 weeks

Secondary Outcomes (1)

  • Assessment of change in Hair Growth Assessment score

    6,12,18 and 24 weeks

Study Arms (6)

Arm A

EXPERIMENTAL

KX-826 2.5mg QD

Drug: KX-826 dosed at 2.5mg

Arm B

EXPERIMENTAL

KX-826 2.5mg BID

Drug: KX-826 dosed at 2.5mg

Arm C

EXPERIMENTAL

KX-826 5mg QD

Drug: KX-826 dosed at 5 mg

Arm D

EXPERIMENTAL

KX-826 5mg BID

Drug: KX-826 dosed at 5 mg

Arm E

PLACEBO COMPARATOR

Matching placebo QD

Drug: Matching placebo to KX-826

Arm F

PLACEBO COMPARATOR

Matching placebo BID

Drug: Matching placebo to KX-826

Interventions

KX-826 dosed at 2.5mgDRUG

2.5mg of the investigational drug to be applied topically to scalp once daily for 24 weeks

Arm A
KX-826 dosed at 5 mgDRUG

5mg of the investigational drug to be applied topically to scalp once daily for 24 weeks

Arm C
Matching placebo to KX-826DRUG

Placebo applied topically to scalp once daily for 24 weeks

Arm E

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who meet all of the following criteria may be included in this study:
  • Agree to follow the study treatment regimen and visit plan, voluntarily enroll in the study and sign the ICF in writing;
  • Female, ≥ 18 years old;
  • Clinically diagnosed as androgenetic alopecia;
  • Alopecia severity was Ggraded D3-D6 according toon Savin scale;
  • Willing to maintain the same hair style, color and length at each follow-up visit;
  • Have no pregnancy plan and agree to take highly effective contraceptives throughout the study and within 3 months after the last dose. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of study drug.

You may not qualify if:

  • Patients who meet any of the following criteria will be excluded from the study:
  • Medical/surgical history of any uncontrolled serious clinical system diseases, which may affect the safety and efficacy evaluation of the study drug, such as circulatory system, nervous system, hematological system, digestive system (e.g., inflammatory bowel disease), immune system, psychiatric disorders, etc.;
  • Known hair loss disorders other than AGA, such as alopecia areata or diffuse alopecia areata, syphilitic alopecia, cicatricial alopecia, malnutrition, alopecia due to chemotherapy/radiotherapy;
  • Scalp skin diseases that affect the efficacy evaluation, scalp trauma, or other scalp skin lesions requiring topical drug therapy, such as fungal or bacterial infection, severe seborrheic dermatitis, scalp psoriasis, contact dermatitis, severe folliculitis and scalp atrophy;
  • Concomitant diseases that affect hair growth, such as connective tissue disease, inflammatory bowel disease, moderate to severe anemia and significant short-term weight loss;
  • History of hair transplantation or requiring long-term wearing of a wig and hair adhesive during the study treatment;
  • Have used topical drugs for hair loss sites (including corticosteroids, estrogens, etc.) that may affect the efficacy evaluation for ≥ 2 consecutive weeks within 3 months prior to screening;
  • Have used androgen replacement therapy, immunosuppressants and other drugs that may affect the efficacy evaluation within 3 months prior to screening;
  • Have used minoxidil within 6 months prior to screening;
  • Have used spironolactone or cyproterone within 6 months prior to screening;
  • Have received autologous platelet-rich plasma therapy for AGA within 12 months prior to screening;
  • Have received chemotherapy and cytotoxic agents within 12 months prior to screening or have received scalp radiation and/or low-energy laser or scalp surgery for AGA within 12 months prior to screening;
  • Have used other medical shampoos or solutions containing ketoconazole or similar ingredients (e.g., Terzolin) that may affect the efficacy evaluation within 1 month prior to screening;
  • Plan to use any adjuvant or concomitant therapy for the treatment of alopecia throughout the study;
  • Allergic to the study drug or known to be allergic to ingredients of the study drug;
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Beijing Friendship Hospital, Capital Medical University

Beijing, China

Location

Beijing Tongren Hospital, Capital Medical University

Beijing, China

Location

China-Japan Friendship Hospital

Beijing, China

Location

Peking University First Hospital

Beijing, China

Location

Peking University People's Hospital

Beijing, China

Location

Xiangya Hospital Central South University

Changsha, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

Dermatology Hospital of Southern Medical University

Guangzhou, China

Location

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

Location

Huashan Hospital, Fudan University

Shanghai, China

Location

Shenzhen People's Hospital

Shenzhen, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, China

Location

Suining Central Hospital

Suining, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, China

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

HypotrichosisHair DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2024

First Posted

May 10, 2024

Study Start

November 9, 2021

Primary Completion

November 10, 2022

Study Completion

December 7, 2023

Last Updated

May 22, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(15)