A Phase Ib Study of HW211026 Ointment in Patients With Actinic Keratosis. (NCT07318675) | Clinical Trial Compass
RecruitingPhase 1
A Phase Ib Study of HW211026 Ointment in Patients With Actinic Keratosis.
China40 participantsStarted 2025-12-25
Plain-language summary
This is a phase Ib study to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) characteristics of HW211026 ointment after single or multiple topical administrations in patients with actinic keratosis.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 cmï¼›
* History of invasive squamous cell carcinoma, Bowen's disease, basal cell carcinoma, or other malignant tumorsï¼›
* 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 de…
What they're measuring
1
The number and severity of treatment emergent adverse events (TEAEs)
Timeframe: up to 28 days
Trial details
NCT IDNCT07318675
SponsorHubei Bio-Pharmaceutical Industrial Technological Institute Inc.