HW211026 ointment for facial actinic keratosis
A Randomized, Double-Blind, Placebo-Controlled, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HW211026 Ointment After Single or Multiple Doses in Subjects With Actinic Keratosis
This will test a new topical ointment, HW211026, on the face to see if it is safe and how the body absorbs and responds to it in people with actinic keratosis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07318675 on ClinicalTrials.gov |
What this trial studies
This phase Ib trial administers single and repeated topical doses of HW211026 ointment to adults with biopsy‑confirmed Olsen grade 1–2 actinic keratosis within a demarcated 100 cm² facial treatment field. Participants will receive HW211026 or placebo and will be closely monitored for safety, tolerability, pharmacokinetics, and pharmacodynamic measures. Key exclusions include atypical or rapidly changing lesions, hypertrophic or hyperkeratotic lesions, single lesions >2 cm, prior invasive skin cancer, and lesions in excluded facial areas such as lips, eyelids, nostrils, or inner ear. The study is conducted at Shanghai Skin Disease Hospital and requires avoidance of direct sunlight/UV exposure for the treatment field during participation.
Who should consider this trial
Good fit: Adults with histopathology‑confirmed Olsen grade 1–2 actinic keratosis confined to a 100 cm² area of the face (excluding lips, perioral, eyelids/periorbital area, nostrils, and inner ear), who can avoid sun/UV exposure and have no history of invasive skin cancer, are ideal candidates.
Not a fit: Patients with clinically atypical, rapidly changing, hypertrophic or hyperkeratotic lesions, a single lesion >2 cm, lesions in excluded facial zones, other skin conditions that interfere with assessment, or prior invasive squamous cell carcinoma or other malignant skin tumors are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, HW211026 could offer a new topical option that safely treats actinic keratosis with predictable local and systemic exposure.
How similar studies have performed: Other topical agents for AK (for example 5‑fluorouracil, imiquimod, diclofenac) have demonstrated efficacy, but HW211026 appears to be a novel compound without published efficacy data to date.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Confirmed as actinic keratosis by histopathology, with Olsen grade 1 or 2. * A 100 cm² treatment field can be demarcated on the face, which covers clinically typical actinic keratosis lesions (excluding lesions on the lips, perioral region, eyelids, periorbital area, inside and around the nostrils, and the inner ear canal). * Willing to avoid direct exposure of the treatment field to sunlight or ultraviolet (UV) radiation during the study. Key Exclusion Criteria: * Subjects with any of the following conditions within the treatment field： * Presence of clinically atypical and/or rapidly changing actinic keratosis lesions, such as hypertrophic lesions, hyperkeratotic lesions, and/or cutaneous horns; * Maximum diameter of a single lesion \> 2 cm； * History of invasive squamous cell carcinoma, Bowen's disease, basal cell carcinoma, or other malignant tumors； * Presence of other skin diseases or conditions that may cause difficulties in examination or evaluation. * treatment field falls within any of the following locations: * Presence of incompletely healed wounds within a 5 cm radius of the treatment field; * Presence of suspected squamous cell carcinoma, basal cell carcinoma, or other tumors within a 5 cm radius of the treatment field. * Subjects with other skin diseases (e.g., atopic dermatitis, psoriasis, eczema, etc.) or other skin conditions (e.g., tattoos, birthmarks, ulcerations, scars, open wounds, etc.) that the investigator deems may interfere with the assessment of safety or efficacy. * Subjects with severe cardiovascular and cerebrovascular diseases. * Receipt of any systemic drug therapy for actinic keratosis within 6 months prior to screening. * Receipt of any topical intervention for actinic keratosis on the administration area within 3 months prior to screening.
Where this trial is running
Shanghai
- Shanghai Skin Disease Hospital — Shanghai, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.