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Combination Topical Therapy for Treatment of Scalp Actinic Keratoses

NCT03996252 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2020-12-07

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • Mayne Pharma International Pty Ltd

    collaborator INDUSTRY

  • Tulane University

    lead OTHER

Principal Investigators

  • Emily Powell, MD · Tulane Department of Dermatology

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2020-01-01
Completion
2020-06-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03996252 on ClinicalTrials.gov