A Phase Ib Study of HW211026 Ointment in Patients With Actinic Keratosis.

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHubei Bio-Pharmaceutical Industrial Technological Institute Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • HW211026
  • Placebo

Treatment groups

40 Participants
are divided into 2 treatment groups