Combination Topical Therapy for Treatment of Scalp Actinic Keratoses

• Status: Terminated
• Trial end date: 2020-06-08
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to determine the effectiveness of combination calcipotriene 0.005% foam and 5% fluorouracil cream for the treatment of actinic keratoses on the scalp. The data obtained will be compared with the current standard of care, monotherapy with 5% fluorouracil cream. A recent randomized, double-blind clinical trial (NCT02019355) compared 0.005% calcipotriol ointment and fluorouracil 5% cream with Vaseline plus fluorouracil 5% cream for a 4-day treatment of actinic keratoses on the face, scalp and upper extremities. They found that calcipotriol plus 5-FU versus Vaseline plus fluorouracil 5% cream led to an 87.8% versus 26.3% mean reduction in the mean number of actinic keratoses. Our study will independently assess the effectiveness of combination treatment (calcipotriene 0.005% foam and fluorouracil 5% cream) on scalp actinic keratoses in a case series of up to 15 eligible participants. Participants will complete a 4-night application of combination treatment with follow-up immediately after and 8 weeks later.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tulane University
• Collaborator: Mayne Pharma International Pty Ltd
• Treatments: Calcipotriene; Calcitriol; Fluorouracil

Criteria

Inclusion Criteria:

• Age of at least 40 years.

• Presence of four to fifteen clinically typical, visible, and discrete actinic keratoses in 25 cm2 on the scalp.

• 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 contains hypertrophic/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 (avoidance of calcipotriene toxicity).