A Phase 2 Study of HW211026

NCT07513454 | Not Yet Recruiting Phase 2

• 1 other identifier: HW211026-201
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Actinic Keratosis

Keywords

HW211026; actinic keratosis

Outcome Measures

Primary Outcomes (1)

• Complete Clearance Rate

  Percentage of participants achieving 100% clearance of actinic keratosis lesions.

  Day 56

Secondary Outcomes (2)

• Change from baseline in lesion counts

  Days 14, 28, 42 and 56

• The number and severity of treatment emergent adverse events (TEAEs)

  Baseline up to Day 57

Study Arms (2)

HW211026 dose 1

EXPERIMENTAL

Drug: HW211026

HW211026 dose 2

EXPERIMENTAL

Drug: HW211026

Interventions

HW211026 DRUG

HW211026 ointment dose 1，applied topically on face once daily.

HW211026 dose 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 years, male or female.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Shanghai Skin Disease Hospital

Shanghai, 200443, China

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 7, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)