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Actinic Keratosis Study (AK)

Primary Purpose

Actinic Keratosis

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
5-fluorouracil 5% cream
Calcipotriol 0.005% ointment
Vaseline
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Actinic Keratosis

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

calcipotriol plus 5-fluorouracil

5-fluorouracil plus vaseline

Arm Description

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 5% cream and vaseline are mixed at 1:1 weight ratio. The compounded medication is applied topically twice a day for 4 days.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2013
Last Updated
May 18, 2016
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02019355
Brief Title
Actinic Keratosis Study
Acronym
AK
Official Title
The Role of Calcipotriol in Treatment of Pre-cancerous Skin Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
calcipotriol plus 5-fluorouracil
Arm Type
Experimental
Arm Description
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.
Arm Title
5-fluorouracil plus vaseline
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
5-fluorouracil 5% cream
Other Intervention Name(s)
Efudex
Intervention Type
Drug
Intervention Name(s)
Calcipotriol 0.005% ointment
Other Intervention Name(s)
Calcipotriene, Dovonex, MC 903
Intervention Type
Drug
Intervention Name(s)
Vaseline
Primary Outcome Measure Information:
Title
percentage of change in the number of actinic keratoses from baseline
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
complete and partial (>75%) clearance of actinic keratoses
Description
o To determine complete and partial (>75%) clearance of actinic keratoses at 8 weeks after treatment.
Time Frame
8wks
Title
Composite score of erythema, itching and skin pain after topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone treatment of actinic keratoses
Description
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.
Time Frame
4days
Title
Induction of TSLP expression in keratinocytes by calcipotriol
Description
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.
Time Frame
4 days
Title
differences in response to topical 5-fluorouracil+calcipotriol vs. 5-fluorouracil alone between the four anatomical sites
Description
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.
Time Frame
8wks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn Cornelius, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63310
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27869649
Citation
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.
Results Reference
derived

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Actinic Keratosis Study

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