A Phase 2 Study of HW211026
ConditionActinic 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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
HW211026
DrugHW211026 ointment dose 1，applied topically on face once daily.
HW211026
DrugHW211026 ointment dose 2，applied topically on face once daily.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: HW211026 dose 1Experimental treatment 1 intervention
Group B: HW211026 dose 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete Clearance Rate
Percentage of participants achieving 100% clearance of actinic keratosis lesions.
Time frame
Day 56Secondary outcomes
1
Change from baseline in lesion counts
Change from baseline in the counts of actinic keratosis lesions.
Time frame
Days 14, 28, 42 and 562
The number and severity of treatment emergent adverse events (TEAEs)
TEAEs were defined as either those AEs with an onset after dosing or those pre-existing conditions that worsened after dosing.
Time frame
Baseline up to Day 57Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: