A Phase 2 Study of HW211026

July 7, 2026 updated by: Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

A Multicenter, Open-label, 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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200443
        • Shanghai Skin Disease Hospital
        • Contact:
          • Guolong Zhang, Doctor
          • Phone Number: +87 021 36803156
          • Email: zglamu@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Aged ≥ 18 years, male or female.
  • 2 to 8 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:

  • Target lesions with any of the following conditions: 1) Clinically atypical and/or rapidly changing actinic keratosis lesions, such as hypertrophic lesions, hyperkeratotic lesions, and/or cutaneous horns. 2) Maximum diameter of a single lesion > 2 cm. 3) Concurrent invasive squamous cell carcinoma, Bowen's disease, basal cell carcinoma or other malignant tumors. 4) Other skin diseases or skin conditions that may interfere with examination or lesion assessment.
  • 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 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Day 56
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
Time Frame: Days 14, 28, 42 and 56
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)
Time Frame: Baseline up to Day 57
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

This is where you will find people and organizations involved with this study.

Sponsor

Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 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)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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