Actinic Keratosis Study (AK)
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ClinicalTrials.gov Identifier: NCT02019355 |
Recruitment Status :
Completed
First Posted : December 24, 2013
Last Update Posted : May 19, 2016
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Condition or disease | Intervention/treatment | Phase |
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Actinic Keratosis | Drug: 5-fluorouracil 5% cream Drug: Calcipotriol 0.005% ointment Drug: Vaseline | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 : | October 2013 |
Actual Primary Completion Date : | March 2015 |
Actual Study Completion Date : | March 2015 |

Arm | Intervention/treatment |
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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.
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Drug: 5-fluorouracil 5% cream
Other Name: Efudex Drug: Calcipotriol 0.005% ointment Other Names:
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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.
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Drug: 5-fluorouracil 5% cream
Other Name: Efudex Drug: Vaseline |
- percentage of change in the number of actinic keratoses from baseline [ Time Frame: 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.
- complete and partial (>75%) clearance of actinic keratoses [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

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Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019355
United States, Missouri | |
Washington University School of Medicine | |
Saint Louis, Missouri, United States, 63310 |
Principal Investigator: | Lynn Cornelius, MD | Washington University School of Medicine |
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: | December 24, 2013 Key Record Dates |
Last Update Posted: | May 19, 2016 |
Last Verified: | December 2013 |
Keratosis, Actinic Keratosis Skin Diseases Precancerous Conditions Neoplasms Fluorouracil Calcipotriene Petrolatum Antimetabolites |
Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Dermatologic Agents Emollients |