HW211026 ointment for facial actinic keratosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Skin Disease Hospital
  Shanghai, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Topical tirbanibulin (Klisyri) for actinic keratoses with downward-directed growth

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.