Not yet recruiting NCT07513454
A Phase 2 Study of HW211026
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HW211026, HW211026.
- Who it may be relevant to
- Registry conditions: Actinic Keratosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Open-label, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HW211026 Ointment in Patients With Actinic Keratosis.
Overview
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
- Drug HW211026
HW211026 ointment dose 1，applied topically on face once daily. - Drug HW211026
HW211026 ointment dose 2，applied topically on face once daily.
Primary outcome measures
- Complete Clearance Rate [Time frame: Day 56]
Secondary outcome measures (2)
- Change from baseline in lesion counts [Time frame: Days 14, 28, 42 and 56]
- The number and severity of treatment emergent adverse events (TEAEs) [Time frame: Baseline up to Day 57]
Eligibility criteria
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.
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Skin Disease Hospital — Shanghai
Identifiers
NCT: NCT07513454 · HW211026-201