Clinical trial NCT03996252: Combination Topical Therapy for Treatment of Scalp Actinic Keratoses
Official title: Combination Calcipotriene 0.005% Foam and Fluorouracil 5% Cream for the Treatment of Actinic Keratoses on the Scalp
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Actinic Keratoses
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Mayne Pharma International Pty Ltd
First posted: 2019-06-24
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Percentage of change in the number of scalp actinic keratoses from baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: Complete and partial (>75%) clearance of actinic keratoses
timeFrame: 8 weeks
measure: 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.
timeFrame: 4 days
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane University Medical Center
state: Louisiana
Study officials:
affiliation: Tulane Department of Dermatology
name: Emily Powell, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.