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AK: Actinic Keratosis Study

Sponsor
Washington University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02019355
Collaborator
(none)
132
Enrollment
1
Location
2
Arms
17
Duration (Months)
7.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: 5-fluorouracil 5% cream
  • Drug: Calcipotriol 0.005% ointment
  • Drug: Vaseline
 Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
132 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Role of Calcipotriol in Treatment of Pre-cancerous Skin Lesions
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: calcipotriol plus 5-fluorouracil

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
Other Names:
  • Efudex

    • Drug: Calcipotriol 0.005% ointment
    Other Names:
  • Calcipotriene
  • Dovonex
  • MC 903

    		•
    Active Comparator: 5-fluorouracil plus 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.

    Drug: 5-fluorouracil 5% cream
    Other Names:
  • Efudex

    • Drug: Vaseline

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Washington University School of Medicine Saint Louis Missouri United States 63310

    Sponsors and Collaborators

    • Washington University School of Medicine

    Investigators

    • Principal Investigator: Lynn Cornelius, MD, Washington University School of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lynn Cornelius, MD, Chief, Division of Dermatology, Washington University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT02019355
    Other Study ID Numbers:
    • 201303070
    First Posted:
    Dec 24, 2013
    Last Update Posted:
    May 19, 2016
    Last Verified:
    Dec 1, 2013
    Additional relevant MeSH terms:
    Keratosis, Actinic
    Keratosis
    Fluorouracil
    Calcipotriene
    Petrolatum

    Study Results

    No Results Posted as of May 19, 2016