Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum

West Virginia University

Status and phase: Not yet enrolling; Phase 1

Conditions: Actinic Keratoses

Treatments: Drug: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH); Drug: 5% 5-fluorouracil (5-FU) powder

Study type: Interventional

Funder types: Other

Identifiers

NCT07401277

2501092203

Details and patient eligibility

About

Actinic keratoses (AKs) are precancerous skin lesions most common among older white individuals and are prevalent throughout West Virginia. There is a risk of progression to cutaneous squamous cell carcinoma (SCC) when lesions are left untreated. Field-directed therapy with topical agents is used for patients with multiple lesions in a contiguous area. We propose that aluminum utilized for hemostasis is a contributing factor in the tumor regression seen after some biopsies and may be effective as an augmenting agent for topical management of AKs. The primary objective of this study is to determine the effectiveness of using aluminum as an augmenting agent in traditional Standard of Care (SOC) topical cream to treat AKs by assessing the response of AKs to treatment with 5% 5-FU plus 15% aluminum chloride hexahydrate (ACH) cream and comparing the reduction in the number/burden of lesions to SOC topical treatment (5% 5-fluorouracil (5-FU)). Photographs and total counts of AKs will be taken by a single dermatologist before (day 0), immediately after (day 8), and 8 weeks after (day 56) treatment.

Enrollment: 32 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Presence of a suspected squamous cell carcinoma (SCC) or basal cell carcinoma (BCC) lesion or open wound on the treatment site (scalp or forearm)

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to 15% ACH or other agents used in this study

• Use of one or more of the following products within the past month:

  • Tanning skin colorants
  • Prescription topical drugs
  • Immunomodulatory or immunosuppressive medicines
  • Chemotherapy or cytotoxic medications
  • Photodynamic therapy (PDT) or other treatments of pre-cancers on the skin
  • Vitamin A derivatives taken by mouth

• Patients receiving any other investigational agents

• Patients with immunosuppression or weakened immune systems who may be at a higher risk of infection, including patients who have had chronic lymphocytic leukemia (CLL), who have received transplants, or who are taking medications such as chronic steroids or rheumatoid arthritis (RA) drugs

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 4 patient groups

Split-Scalp: Left Investigational / Right SOC

Experimental group

Description:

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.

Treatment:

Drug: 5% 5-fluorouracil (5-FU) powder

Drug: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH)

Split-Scalp: Left SOC / Right Investigational

Experimental group

Description:

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.

Treatment:

Drug: 5% 5-fluorouracil (5-FU) powder

Drug: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH)

Split-Forearm: Left Investigational / Right SOC

Experimental group

Description:

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.

Treatment:

Drug: 5% 5-fluorouracil (5-FU) powder

Drug: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH)

Split-Forearm: Left SOC / Right Investigational

Experimental group

Description:

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.

Treatment:

Drug: 5% 5-fluorouracil (5-FU) powder

Drug: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH)