Actinic Keratosis
Conditions
Keywords
HW211026, actinic keratosis
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.
Interventions
DRUGHW211026
HW211026 ointment dose 1，applied topically on face once daily.
Sponsors
Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Clearance Rate | Day 56 | Percentage of participants achieving 100% clearance of actinic keratosis lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in lesion counts | Days 14, 28, 42 and 56 | Change from baseline in the counts of actinic keratosis lesions. |
| The number and severity of treatment emergent adverse events (TEAEs) | 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. |
Countries
China
Outcome results
None listed