Actinic Keratosis Study

NCT02019355 | Completed Early Phase 1 DMC

• 1 other identifier: 201303070
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

• percentage of change in the number of actinic keratoses from baseline

  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.

  8 weeks

Secondary Outcomes (4)

• complete and partial (>75%) clearance of actinic keratoses

  8wks

• Composite score of erythema, itching and skin pain after topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone treatment of actinic keratoses

  4days

• Induction of TSLP expression in keratinocytes by calcipotriol

  4 days

• differences in response to topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone between the four anatomical sites

  8wks

Study Arms (2)

calcipotriol plus 5-fluorouracil

EXPERIMENTAL

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.

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

5-fluorouracil plus vaseline

ACTIVE COMPARATOR

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.

Drug: 5-fluorouracil 5% cream; Drug: Vaseline

Interventions

5-fluorouracil 5% cream DRUG

Also known as: Efudex

5-fluorouracil plus vaseline; calcipotriol plus 5-fluorouracil

Calcipotriol 0.005% ointment DRUG

Also known as: Calcipotriene, Dovonex, MC 903

calcipotriol plus 5-fluorouracil

Vaseline DRUG

5-fluorouracil plus vaseline

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63310, United States

Location

Related Publications (1)

• Cunningham TJ, Tabacchi M, Eliane JP, Tuchayi SM, Manivasagam S, Mirzaalian H, Turkoz A, Kopan R, Schaffer A, Saavedra AP, Wallendorf M, Cornelius LA, Demehri S. Randomized trial of calcipotriol combined with 5-fluorouracil for skin cancer precursor immunotherapy. J Clin Invest. 2017 Jan 3;127(1):106-116. doi: 10.1172/JCI89820. Epub 2016 Nov 21.

  PMID: 27869649 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Fluorouracil; calcipotriene; Ointments; Petrolatum

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Hydrocarbons; Organic Chemicals

Study Officials

• Lynn Cornelius, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Dermatology

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 24, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 19, 2016

Record last verified: 2013-12

Locations

US (1)