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Combination Topical Therapy for Treatment of Scalp Actinic Keratoses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03996252
Recruitment Status : Not yet recruiting
First Posted : June 24, 2019
Last Update Posted : June 24, 2019
Sponsor:
Collaborator:
Mayne Pharma International Pty Ltd
Information provided by (Responsible Party):
Tulane University

Brief Summary:
The aim of this study is to determine the effectiveness of combination calcipotriene 0.005% foam and 5% fluorouracil cream for the treatment of actinic keratoses on the scalp. The data obtained will be compared with the current standard of care, monotherapy with 5% fluorouracil cream. A recent randomized, double-blind clinical trial (NCT02019355) compared 0.005% calcipotriol ointment and fluorouracil 5% cream with Vaseline plus fluorouracil 5% cream for a 4-day treatment of actinic keratoses on the face, scalp and upper extremities. They found that calcipotriol plus 5-FU versus Vaseline plus fluorouracil 5% cream led to an 87.8% versus 26.3% mean reduction in the mean number of actinic keratoses. Our study will independently assess the effectiveness of combination treatment (calcipotriene 0.005% foam and fluorouracil 5% cream) on scalp actinic keratoses in a case series of up to 15 eligible participants. Participants will complete a 4-night application of combination treatment with follow-up immediately after and 8 weeks later.

Condition or disease Intervention/treatment Phase
Actinic Keratoses Drug: Calcipotriene 0.005% Foam Drug: Efudex 5% Topical Cream Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combination Calcipotriene 0.005% Foam and Fluorouracil 5% Cream for the Treatment of Actinic Keratoses on the Scalp
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : June 8, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Combination treatment arm
Combination of calcipotriene 0.005% foam (Sorilux) and Fluorouracil Cream, 5% USP (generic) applied for four consecutive nights for the treatment of scalp actinic keratoses.
Drug: Calcipotriene 0.005% Foam
Application of calcipotriene foam in conjunction with generic efudex cream to the scalp for four consecutive nights for the treatment of scalp actinic keratoses
Other Names:
  • Calcipotriene
  • Sorilux

Drug: Efudex 5% Topical Cream
Application of generic efudex cream in conjunction with calcipotriene foam to the scalp for four consecutive nights for the treatment of scalp actinic keratoses
Other Names:
  • Efudex
  • 5-fluorouracil 5% cream




Primary Outcome Measures :
  1. Percentage of change in the number of scalp actinic keratoses from baseline [ Time Frame: 8 weeks ]
    Determine the efficacy of calcipotriene 0.005% foam and 5-fluorouracil 5% cream for the treatment of scalp actinic keratoses following 4 nights of combination treatment. The outcome of interest is percentage change from baseline number of actinic keratoses in the target treatment area on scalp at 8 weeks after treatment.


Secondary Outcome Measures :
  1. Complete and partial (>75%) clearance of actinic keratoses [ Time Frame: 8 weeks ]
    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 of calcipotriene 0.005% foam and 5-fluorouracil 5% cream application for four consecutive nights to scalp actinic keratoses. [ Time Frame: 4 days ]
    To determine the composite scores of erythema, itching and pain (determined using standardized scales) following topical application of of calcipotriene 0.005% foam and 5-fluorouracil 5% cream application for four consecutive nights to scalp actinic keratoses.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age of at least 40 years.
  • Presence of four to fifteen clinically typical, visible, and discrete actinic keratoses in 25 cm2 on the scalp.
  • 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 contains hypertrophic/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 (avoidance of calcipotriene toxicity).

Information from the National Library of Medicine

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): NCT03996252


Contacts
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Contact: Emily Powell, MD 4058163825 epowell4@tulane.edu
Contact: Laura Williams, MD 5046060506 lwilliams@tulane.edu

Sponsors and Collaborators
Tulane University
Mayne Pharma International Pty Ltd
Investigators
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Principal Investigator: Emily Powell, MD Tulane Department of Dermatology
Publications:
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Responsible Party: Tulane University
ClinicalTrials.gov Identifier: NCT03996252    
Other Study ID Numbers: 052090
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms
Calcitriol
Fluorouracil
Calcipotriene
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents