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NCT Number: NCT07513454

A Phase 2 Study of HW211026

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Aged ≥ 18 years, male or female.
  • 2 to 8 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.

Key Exclusion Criteria:

  • Target lesions with any of the following conditions: 1) Clinically atypical and/or rapidly changing actinic keratosis lesions, such as hypertrophic lesions, hyperkeratotic lesions, and/or cutaneous horns. 2) Maximum diameter of a single lesion > 2 cm. 3) Concurrent invasive squamous cell carcinoma, Bowen's disease, basal cell carcinoma or other malignant tumors. 4) Other skin diseases or skin conditions that may interfere with examination or lesion assessment.
  • 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 have undergone major surgery within 3 months prior to screening, or who plan to undergo surgery during the trial, as determined by the investigator.
  • Participants who have participated in any investigational drug clinical trial and received an investigational product within 3 months prior to screening.

Treatment and study plan

HW211026

Drug

HW211026 ointment dose 1,applied topically on face once daily.

Primary outcomes

  1. Complete Clearance Rate

    Time frame: Day 56

    Percentage of participants achieving 100% clearance of actinic keratosis lesions.

Secondary outcomes

  1. Change from baseline in lesion counts

    Time frame: Days 14, 28, 42 and 56

    Change from baseline in the counts of actinic keratosis lesions.

  2. The number and severity of treatment emergent adverse events (TEAEs)

    Time frame: Baseline up to Day 57

    TEAEs were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing.

Sponsors and collaborators

Lead sponsor

Hubei Bio-Pharmaceutical Industrial Technological Institute Inc.

Industry

Registry information

Official study title

A Multicenter, Open-label, Phase II Clinical Trial to Evaluate the Efficacy and Safety of HW211026 Ointment in Patients With Actinic Keratosis.

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Apr 7, 2026
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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