Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled, Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HW211026 Ointment After Single or Multiple Doses in Subjects With Actinic Keratosis
Led by Hubei Bio-Pharmaceutical Industrial Technological Institute Inc. · Updated on 2026-01-06
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes and responds to HW211026 ointment in patients with actinic keratosis. This is a phase Ib study focusing on single or multiple topical applications of the ointment in adults with this skin condition. The study aims to understand both the pharmacokinetic and pharmacodynamic properties of the treatment compared to a placebo. Participants will receive either HW211026 ointment or a placebo applied to the skin in single or multiple doses. The study is randomized and double-blinded, meaning neither the participants nor the researchers know who receives the active ointment or placebo. The treatment area is a 100 cm² field on the face, excluding sensitive regions such as lips, eyelids, and nostrils. Participants are asked to avoid direct sun or UV exposure on the treated area during the study. During the study, participants will be monitored for any treatment-emergent adverse events up to 28 days. Blood samples will be collected up to 10 days to measure drug concentration levels and how long the drug stays in the body. Researchers will also evaluate the severity and number of side effects, with ongoing safety assessments. The total study duration includes treatment and follow-up periods to ensure comprehensive monitoring of effects and tolerability.
CONDITIONS
Brief Title
A Phase Ib Study of HW211026 Ointment in Patients With Actinic Keratosis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed actinic keratosis diagnosed by biopsy with Olsen grade 1 or 2.
- A 100 cm² treatment area can be marked on the face covering typical actinic keratosis lesions, excluding lips, perioral region, eyelids, periorbital area, nostrils, and inner ear canal.
- Willingness to avoid direct sunlight or UV exposure on the treatment area during the study.
- Age 18 years or older.
You will not qualify if you...
- Presence of atypical or rapidly changing actinic keratosis lesions such as hypertrophic, hyperkeratotic lesions, or cutaneous horns within the treatment field.
- 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 that may interfere with examination or evaluation.
- Treatment field includes incompletely healed wounds within 5 cm radius.
- Suspected skin cancers or tumors within 5 cm radius of treatment area.
- Presence of other skin diseases like atopic dermatitis, psoriasis, eczema, tattoos, birthmarks, ulcerations, scars, or open wounds that may affect safety or efficacy assessment.
- Severe cardiovascular or cerebrovascular diseases.
- Use of systemic treatment for actinic keratosis within 6 months before screening.
- Use of topical treatment for actinic keratosis on the study area within 3 months before screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 28 days
Participants receive single or multiple topical doses of HW211026 ointment or placebo applied to the treatment area.
1 to 2 visits depending on dosing schedule
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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