CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 120 enrolled
Drug / intervention
KX-826-2.5 mg (0.25%)/60 mL BID +3 moredrug
Likely dose
KX-826-2.5 mg (0.25%)/60 mL BIDfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05940506
NCT05940506Phase 2Completed

A Phase II Clinical Study to Evaluate the Efficacy and Safety of KX-826 Tincture in the Treatment of Adult Male Androgenetic Alopecia (AGA) Patients in China

Suzhou Kintor Pharmaceutical Inc,·interventional·Posted Jul 11, 2023·Updated Jul 19, 2023

In Brief

A Phase 2 clinical trial evaluating KX-826-2.5 mg (0.25%)/60 mL BID, KX-826-5 mg (5%)/60 mL QD, and 2 other interventions for Androgenetic Alopecia (AGA). Completed, enrolled 120 participants across 9 sites.

Detailed Summary

This is a multi-center, randomized, double-blind, placebo-controlled Phase II clinical study of KX-826 in Chinese adult male patients with AGA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJul 11, 2023
Enrollment StartSep 28, 2020
Primary CompletionJul 8, 2021
Study CompletionAug 18, 2021
TodayJul 1, 2026
Enrollment to primary: 9 monthsPosted 3.0 years ago

Interventions

KX-826-2.5 mg (0.25%)/60 mL BIDdrug

Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered once in the morning and once in the evening.

KX-826-5 mg (5%)/60 mL QDdrug

Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered in the evening once daily.

KX-826-5 mg (5%)/60 mL BIDdrug

Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm), starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered once in the morning and once in the evening.

Placeboother

Topical application, 7 sprays (approximately 1 mL)/time, in the target area of the scalp (8 cm × 8 cm),starting from the center of the affected area, and massage with hands for 3-5 min. This dose is used regardless of the size of the affected area. It should be used when hair and scalp are completely dry. Wash hands after use. The control product will be administered in the evening once daily for QD dose groups, and once in the morning and once in the evening for the BID dose groups.