Actinic Keratosis Study (AK)

The Washington University

Status and phase: Completed; Early Phase 1

Conditions: Actinic Keratosis

Treatments: Drug: 5-fluorouracil 5% cream; Drug: Calcipotriol 0.005% ointment; Drug: Vaseline

Study type: Interventional

Funder types: Other

Identifiers

NCT02019355

201303070

Details and patient eligibility

About

The main purpose of this study is to determine the effectiveness of a new combination therapy for actinic keratosis. This study investigates a new indication for an FDA-approved topical medication, calcipotriol, for treatment of actinic keratosis, including how well it works and how safe it is when used in combination with the standard of care medication (5-fluorouracil) for the skin condition.

Enrollment: 132 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age of at least 50 years
• Presence of four to fifteen clinically typical, visible, and discrete actinic keratoses in 25 cm2 on any of the four anatomical sites: scalp, face, right upper extremity and left upper extremity
• Ability and willingness of the patient to participate in the study (Informed consent is obtained)

Exclusion criteria

• Treatment area is within 5 cm of an incompletely healed wound or a suspected basal-cell or squamous-cell carcinoma
• Treatment area contained hypertrophic and hyperkeratotic lesions, cutaneous horns, or lesions that had not responded to repeated cryotherapy
• Recent (within a month) use of medications that could interfere with evaluation of the treatment area (e.g., topical medications, artificial tanners, immunosuppressive medications, immunomodulating agents, cytotoxic drugs, ultraviolet B phototherapy, other therapies for actinic keratoses, or oral retinoids)
• Premenopausal Women (to avoid any risk of pregnancy)
• History of hypercalcemia or clinical evidence of vitamin D toxicity

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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132 participants in 2 patient groups

calcipotriol plus 5-fluorouracil

Experimental group

Description:

calcipotriol 0.005% ointment and 5-fluorouracil 5% cream are mixed at 1:1 weight ratio. The compounded medication is applied topically twice a day for 4 days.

Treatment:

Drug: Calcipotriol 0.005% ointment

Drug: 5-fluorouracil 5% cream

5-fluorouracil plus vaseline

Active Comparator group

Description:

5-fluorouracil 5% cream and vaseline are mixed at 1:1 weight ratio. The compounded medication is applied topically twice a day for 4 days.

Treatment:

Drug: Vaseline

Drug: 5-fluorouracil 5% cream