About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
HW211026
DrugHW211026 ointment dose 1,applied topically on face once daily.
HW211026
DrugHW211026 ointment dose 2,applied topically on face once daily.
Treatment groups
Trial outcomes
Primary outcomes
Complete Clearance Rate
Percentage of participants achieving 100% clearance of actinic keratosis lesions.
Secondary outcomes
Change from baseline in lesion counts
Change from baseline in the counts of actinic keratosis lesions.
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.
Locations
Sponsors and contacts
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