Actinic Keratosis Study

Early Phase 1

Completed

• Conditions: Actinic Keratosis
• Interventions: Drug: 5-fluorouracil 5% cream; Drug: Calcipotriol 0.005% ointment; Drug: Vaseline

• Registration Number: NCT02019355
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Status Verified: 2013-12
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-24
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5-fluorouracil plus vaseline	5-fluorouracil 5% cream	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.
calcipotriol plus 5-fluorouracil	Calcipotriol 0.005% ointment	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.
5-fluorouracil plus vaseline	Vaseline	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.
calcipotriol plus 5-fluorouracil	5-fluorouracil 5% cream	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.

Primary Outcome Measures

Name	Time	Method
percentage of change in the number of actinic keratoses from baseline	8 weeks	To compare the efficacy of topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone in treatment of actinic keratosis in patients with multiple actinic keratoses at each of the four anatomical sites (scalp, face, right upper extremity and left upper extremity). The outcome of interest is percentage change from baseline number of actinic keratoses in the target treatment area on scalp, face, right upper extremity and left upper extremity at 8 weeks after treatment.

Secondary Outcome Measures

Name	Time	Method
complete and partial (>75%) clearance of actinic keratoses	8wks	o To determine complete and partial (\>75%) clearance of actinic keratoses at 8 weeks after treatment.
Composite score of erythema, itching and skin pain after topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone treatment of actinic keratoses	4days	To determine the composite scores of erythema, itching and pain (determined using standardized scales) following topical application of 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone at the end of the 4-day treatment period.
Induction of TSLP expression in keratinocytes by calcipotriol	4 days	To examine the induction of TSLP expression in keratinocytes by calcipotriol at the site of the actinic keratoses at the end of 4-day treatment of course.
differences in response to topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone between the four anatomical sites	8wks	To determine any differences in response to topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone between the four anatomical sites at 8 weeks after treatment.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States