Combination Topical Therapy for Treatment of Scalp Actinic Keratoses

Study Overview
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Brief Summary
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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.

Official Title
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Combination Calcipotriene 0.005% Foam and Fluorouracil 5% Cream for the Treatment of Actinic Keratoses on the Scalp

Conditions
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Actinic Keratoses

Intervention / Treatment
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* Drug: Calcipotriene 0.005% Foam
* Drug: Efudex 5% Topical Cream


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination treatment arm<br>Combination of calcipotriene 0.005% foam (Sorilux) and Fluorouracil Cream, 5% USP (generic) applied for four consecutive nights for the treatment of scalp actinic keratoses. | Drug: Calcipotriene 0.005% Foam<br>* Application of calcipotriene foam in conjunction with generic efudex cream to the scalp for four consecutive nights for the treatment of scalp actinic keratoses<br>* Other names: Sorilux;Drug: Efudex 5% Topical Cream<br>* Application of generic efudex cream in conjunction with calcipotriene foam to the scalp for four consecutive nights for the treatment of scalp actinic keratoses<br>* Other names: 5-fluorouracil 5% cream;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of change in the number of scalp actinic keratoses from baseline | Determine the efficacy of calcipotriene 0.005% foam and 5-fluorouracil 5% cream for the treatment of scalp actinic keratoses following 4 nights of combination treatment. The outcome of interest is percentage change from baseline number of actinic keratoses in the target treatment area on scalp at 8 weeks after treatment. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete and partial (>75%) clearance of actinic keratoses | To determine complete and partial (>75%) clearance of actinic keratoses at 8 weeks after treatment. | 8 weeks | 
| Composite score of erythema, itching and skin pain after topical of calcipotriene 0.005% foam and 5-fluorouracil 5% cream application for four consecutive nights to scalp actinic keratoses. | To determine the composite scores of erythema, itching and pain (determined using standardized scales) following topical application of of calcipotriene 0.005% foam and 5-fluorouracil 5% cream application for four consecutive nights to scalp actinic keratoses. | 4 days |