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New treatment option for Actinic Keratosis (AK)
Official title A Phase Ib Study of HW211026 Ointment in Patients With Actinic Keratosis.
ClinicalTrials.gov ID: NCT07318675
What this study is testing
What is HW211026?
HW211026 is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for actinic keratosis (ak).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Confirmed as actinic keratosis by histopathology, with Olsen grade 1 or 2.
- A 100 cm² treatment field can be demarcated on the face, which covers clinically typical actinic keratosis lesions (excluding lesions on the lips...
- Willing to avoid direct exposure of the treatment field to sunlight or ultraviolet (UV) radiation during the study. Key
You likely can't join if
- people with any of the following conditions within the treatment field：
- Presence of clinically atypical and/or rapidly changing actinic keratosis lesions, such as hypertrophic lesions, hyperkeratotic lesions, and/or...
- Maximum diameter of a single lesion \> 2 cm；
- History of invasive squamous cell carcinoma, Bowen's disease, basal cell carcinoma, or other malignant tumors；
- Presence of other skin diseases or conditions that may cause difficulties in examination or evaluation.
- treatment field falls within any of the following locations:
See the full eligibility criteria
- Confirmed as actinic keratosis by histopathology, with Olsen grade 1 or 2.
- A 100 cm² treatment field can be demarcated on the face, which covers clinically typical actinic keratosis lesions (excluding lesions on the lips, perioral region, eyelids, periorbital area, inside and around the...
- Willing to avoid direct exposure of the treatment field to sunlight or ultraviolet (UV) radiation during the study. Key
- people with any of the following conditions within the treatment field：
- Presence of clinically atypical and/or rapidly changing actinic keratosis lesions, such as hypertrophic lesions, hyperkeratotic lesions, and/or cutaneous horns;
- Maximum diameter of a single lesion \> 2 cm；
- History of invasive squamous cell carcinoma, Bowen's disease, basal cell carcinoma, or other malignant tumors；
- Presence of other skin diseases or conditions that may cause difficulties in examination or evaluation.
- treatment field falls within any of the following locations:
- Presence of incompletely healed wounds within a 5 cm radius of the treatment field;
- Presence of suspected squamous cell carcinoma, basal cell carcinoma, or other tumors within a 5 cm radius of the treatment field.
- people with other skin diseases (e.g., atopic dermatitis, psoriasis, eczema, etc.) or other skin conditions (e.g., tattoos, birthmarks, ulcerations, scars, open wounds, etc.) that the investigator deems may interfere...
- people with severe cardiovascular and cerebrovascular diseases.
- Receipt of any systemic drug therapy for actinic keratosis within 6 months prior to screening.
- Receipt of any topical intervention for actinic keratosis on the administration area within 3 months prior to screening.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.