A Phase 2 Study of HW211026 in Participants With Actinic Keratosis

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHubei Bio-Pharmaceutical Industrial Technological Institute Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Aged ≥ 18 years, male or female.

At least 2 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.

Disqualifiers

Clinically atypical and/or rapidly changing actinic keratosis lesions, such as hypertrophic lesions, hyperkeratotic lesions, and/or cutaneous horns.

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 are unable to discontinue immunomodulators, immunosuppressants, cytotoxic agents, or corticosteroids from 1 month prior to signing the informed consent form until study completion or early withdrawal.

Trial design

Treatments tested in this trial

  • HW211026
  • HW211026

Treatment groups

80 Participants
are divided into 2 treatment groups

Locations

This trial has no locations