Combination Topical Therapy for Treatment of Scalp Actinic Keratoses

NCT03996252 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: 052090
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (1)

• Percentage of change in the number of scalp actinic keratoses from baseline

  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.

  8 weeks

Secondary Outcomes (2)

• Complete and partial (>75%) clearance of actinic keratoses

  8 weeks

• 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.

  4 days

Study Arms (1)

Combination treatment arm

EXPERIMENTAL

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; Drug: Efudex 5% Topical Cream

Interventions

Calcipotriene 0.005% Foam DRUG

Application of calcipotriene foam in conjunction with generic efudex cream to the scalp for four consecutive nights for the treatment of scalp actinic keratoses

Also known as: Calcipotriene, Sorilux

Combination treatment arm

Efudex 5% Topical Cream DRUG

Application of generic efudex cream in conjunction with calcipotriene foam to the scalp for four consecutive nights for the treatment of scalp actinic keratoses

Also known as: Efudex, 5-fluorouracil 5% cream

Combination treatment arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Tulane University: lead
• Mayne Pharma International Pty Ltd: collaborator

Study Sites (1)

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Related Publications (1)

• 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.

  PMID: 27869649 BACKGROUND

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

calcipotriene; Fluorouracil

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Emily Powell, MD

  Tulane Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 24, 2019
• Study Start: July 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: June 8, 2020
• Last Updated: December 7, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)