Actinic Keratosis Clinical Trials

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Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum: an Exploratory Study

Status: Recruiting

Location: See location...

Intervention Type: Drug

Study Type: Interventional

Study Phase: Phase 1

SUMMARY

This study is looking at a new way to treat actinic keratoses, which are rough, scaly spots on the skin caused by long-term sun exposure. These spots are common in older adults and, if not treated, can sometimes develop into a type of skin cancer. Doctors often treat areas with many of these spots by using a prescription cream called 5-fluorouracil (5-FU), which helps remove damaged skin cells. This study is testing whether adding aluminum chloride hexahydrate, a medication commonly used to stop bleeding during skin procedures, can improve how well the cream works. People who take part in this study will receive one of two treatments applied to their skin: Standard treatment with 5% 5-fluorouracil cream, or A combination of 5% 5-fluorouracil cream plus 15% aluminum chloride hexahydrate cream The treatment will be applied for one week. A dermatologist will examine the treated skin areas, count the number of actinic keratoses, and take photographs before treatment begins, shortly after treatment ends, and again about eight weeks later. These visits help researchers compare how well each treatment reduces the number of skin spots over time. The goal of this study is to learn whether adding aluminum chloride hexahydrate to standard treatment helps reduce actinic keratoses more effectively than standard treatment alone.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Maximum Age: 50

Healthy Volunteers: f

View:

• Less than 50 years due to this being a pathology of adults that develops in chronically sun-damaged skin, individuals \<50 years of age are excluded from this study.

• Patients with 4-15 clinically diagnosed AKs on the scalp (16 patients) or on the forearms (16 patients) being followed at the Mohs Surgery clinic by WVU Medicine Dermatology

• Performance status: ECOG Performance status less than or equal to 2

• Patient must provide informed consent

Locations

United States

West Virginia

West Virginia University

RECRUITING

Morgantown

Contact Information

Primary

Vlad Codrea, MD, PhD

vlad.codrea@hsc.wvu.edu

304-598-4548

Time Frame

Start Date: 2026-02-06

Estimated Completion Date: 2027-08

Participants

Target number of participants: 32

Treatments

Experimental: Split-Scalp: Left Investigational / Right SOC

Participants clinically diagnosed with actinic keratoses (AKs) on the scalp will apply investigational cream (5% 5-fluorouracil \[5-FU\] + 15% acetyl cysteine \[ACH\]) to AK lesions on the left half of the scalp and standard of care (SOC) cream (5% 5-FU) to AK lesions on the right half of the scalp. Assignment is determined by sealed, randomized envelopes indicating Container A to left (with Container B to right); the identity of A vs B (SOC vs investigational) is blinded to participants and investigators.

Experimental: Split-Scalp: Left SOC / Right Investigational

Participants clinically diagnosed with AKs on the scalp will apply SOC cream (5% 5-FU) to AK lesions on the left half of the scalp and investigational cream (5% 5-FU + 15% ACH) to AK lesions on the right half of the scalp. Assignment is determined by sealed, randomized envelopes indicating Container A to right (with Container B to left); the identity of A vs B (SOC vs investigational) is blinded to participants and investigators.

Experimental: Split-Forearm: Left Investigational / Right SOC

Participants clinically diagnosed with AKs on the forearms will apply investigational cream (5% 5-FU + 15% ACH) to AK lesions on the left forearm and SOC cream (5% 5-FU) to AK lesions on the right forearm. Assignment is determined by sealed, randomized envelopes indicating Container A to left (with Container B to right); the identity of A vs B (SOC vs investigational) is blinded to participants and investigators.

Experimental: Split-Forearm: Left SOC / Right Investigational

Participants clinically diagnosed with AKs on the forearms will apply SOC cream (5% 5-FU) to AK lesions on the left forearm and investigational cream (5% 5-FU + 15% ACH) to AK lesions on the right forearm. Assignment is determined by sealed, randomized envelopes indicating Container A to right (with Container B to left); the identity of A vs B (SOC vs investigational) is blinded to participants and investigators.

Related Therapeutic Areas

Actinic Keratosis

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