A Phase 2 Study of HW211026 in Participants With Actinic Keratosis

A Multicenter, Randomized, Open-label, Parallel-group, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HW211026 Ointment in Patients With Actinic Keratosis.

This is a multicenter, randomized, open-label, parallel-group, Phase II clinical trial designed to evaluate the efficacy and safety of HW211026 in adult patients with actinic keratosis.

Study Overview

• Status: Not yet recruiting
• Conditions: Actinic Keratosis
• Intervention / Treatment: Drug: HW211026; Drug: HW211026

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Aged ≥ 18 years, male or female.
• At least 2 clinically typical target actinic keratosis lesions on the face.
• Willing to avoid direct sun or ultraviolet exposure to the treatment area during the trial.
• Fully informed about the study, voluntarily sign the informed consent form, and be able to comply with study procedures and follow-up examination requirements.

Key Exclusion Criteria:

• Clinically atypical and/or rapidly changing actinic keratosis lesions, such as hypertrophic lesions, hyperkeratotic lesions, and/or cutaneous horns.
• Presence of incompletely healed wounds or suspected squamous cell carcinoma, basal cell carcinoma, or other malignant tumors within 5 cm of the actinic keratosis lesions.
• Participants with other skin diseases or skin conditions that, in the investigator's judgment, may interfere with the evaluation of safety or efficacy.
• Participants who are unable to discontinue immunomodulators, immunosuppressants, cytotoxic agents, or corticosteroids from 1 month prior to signing the informed consent form until study completion or early withdrawal.
• Participants who have undergone major surgery within 3 months prior to screening, or who plan to undergo surgery during the trial, as determined by the investigator.
• Participants who have participated in any investigational drug clinical trial and received an investigational product within 3 months prior to screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HW211026 dose 1	Drug: HW211026; HW211026 ointment dose 1，applied topically on face once daily.; Drug: HW211026; HW211026 ointment dose 2，applied topically on face once daily.
Experimental: HW211026 dose 2	Drug: HW211026; HW211026 ointment dose 1，applied topically on face once daily.; Drug: HW211026; HW211026 ointment dose 2，applied topically on face once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Clearance Rate	Percentage of participants achieving 100% clearance of actinic keratosis lesions.	Day 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in lesion counts	Change from baseline in the counts of actinic keratosis lesions.	Days 14, 28, 42 and 56
The number and severity of treatment emergent adverse events (TEAEs)	TEAEs were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing.	Baseline up to Day 57

Collaborators and Investigators

• Sponsor: Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 7, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Skin Diseases; Precancerous Conditions; Keratosis; Skin and Connective Tissue Diseases; Keratosis, Actinic
• Other Study ID Numbers: HW211026-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No