A Phase 2 Study of HW211026

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.

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.