Actively Recruiting
A Phase Ib Study of HW211026 Ointment in Patients With Actinic Keratosis.
Led by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. · Updated on 2026-01-06
40
Participants Needed
1
Research Sites
9 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase Ib Study of HW211026 Ointment in Patients With Actinic Keratosis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of actinic keratosis by histopathology with Olsen grade 1 or 2
- Ability to mark a 100 cm² treatment area on the face covering typical actinic keratosis lesions, excluding lips, perioral region, eyelids, periorbital area, inside and around nostrils, and inner ear canal
- Willingness to avoid direct sunlight or UV radiation exposure on the treatment area during the study
You will not qualify if you...
- Presence of clinically atypical or rapidly changing actinic keratosis lesions such as hypertrophic, hyperkeratotic lesions, or cutaneous horns within the treatment field
- Any single lesion larger than 2 cm in diameter
- History of invasive squamous cell carcinoma, Bowen's disease, basal cell carcinoma, or other malignant tumors
- Other skin diseases or conditions in the treatment field that interfere with examination or evaluation
- Treatment field includes incompletely healed wounds within 5 cm radius
- Presence of suspected squamous cell carcinoma, basal cell carcinoma, or other tumors within 5 cm radius of treatment field
- Other skin diseases or conditions (e.g., atopic dermatitis, psoriasis, eczema, tattoos, birthmarks, ulcerations, scars, open wounds) that may interfere with safety or efficacy assessment
- Severe cardiovascular or cerebrovascular diseases
- Use of systemic drug therapy for actinic keratosis within 6 months before screening
- Use of topical treatment for actinic keratosis in the administration area within 3 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Skin Disease Hospital
Shanghai, China, 200443
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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