Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorWest Virginia University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Tanning skin colorants

Prescription topical drugs

Trial design

Design model

Parallel

Treatments tested in this trial

  • 5% 5-fluorouracil (5-FU) powder

    Drug

    Standard of care topical fluorouracil 5% cream, applied twice daily for seven consecutive days to designated side's AK lesions per protocol regimen.

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

    Drug

    Investigational topical combination of fluorouracil 5% and acetyl cysteine 15%, applied twice daily for seven consecutive days to designated side's AK lesions per protocol regimen.

Treatment groups

32 Participants
are divided into 4 treatment groups
Group A: Split-Scalp: Left Investigational / Right SOCExperimental treatment 2 interventions
Group B: Split-Scalp: Left SOC / Right InvestigationalExperimental treatment 2 interventions
Group C: Split-Forearm: Left Investigational / Right SOCExperimental treatment 2 interventions
Group D: Split-Forearm: Left SOC / Right InvestigationalExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of Actinic Keratoses; Baseline

Total numerical counts of actinic keratoses (AKs) assessed and documented.

Time frame
Baseline
2

Number of Actinic Keratoses; Day 8

Total numerical counts of actinic keratoses (AKs) assessed and documented.

Time frame
Day 8
3

Number of Actinic Keratoses; Day 56

Total numerical counts of actinic keratoses (AKs) assessed and documented.

Time frame
Day 56

Secondary outcomes

1

Skin redness at treatment site(s); Day 8

Redness will be assessed using a scale of 0-4 as per the Clinical Erythema Assessment grading scale with: 0 = clear, 1 = almost clear, 2 = mild erythema, 3 = moderate erythema, and 4 = severe erythema with 0 being the best outcome.

Time frame
Day 8
2

Skin redness at treatment site(s); Day 56

Redness will be assessed using a scale of 0-4 as per the Clinical Erythema Assessment grading scale with: 0 = clear, 1 = almost clear, 2 = mild erythema, 3 = moderate erythema, and 4 = severe erythema with 0 being the best outcome.

Time frame
Day 56
3

Skin itchiness at treatment site(s); Day 8

Itchiness will be assessed using the Peak Pruritus Numeric Rating Scale (NRS) of 0-10 reported by the patient, with 0 being no itchiness and 10 being the worst itchiness ever experienced.

Time frame
Day 8
4

Skin itchiness at treatment site(s); Day 56

Itchiness will be assessed using the Peak Pruritus Numeric Rating Scale (NRS) of 0-10 reported by the patient, with 0 being no itchiness and 10 being the worst itchiness ever experienced.

Time frame
Day 56

Other outcomes

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