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Ingenol Mebutate (Picato®) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis

NCT02354391 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-03-26

No results posted yet for this study

Summary

The objective of this study is to determine the efficacy, safety, and patient satisfaction of pretreatment with Picato® gel 4 days prior to methyl aminolevulinate photodynamic therapy (MAL PDT). Patients diagnosed with actinic keratosis who are eligible to receive topical treatment with ingenol mebutate (Picato®) and photodynamic therapy will act both as the test group and the control group. Each patient will have four distinct treatment areas of 25cm2 on the scalp, and/or scalp and face. Three of the treatment areas will receive Picato® 0.015% gel, MAL PDT, or Picato® 0.015% and MAL PDT combined. One area will serve as a control and will receive none of the treatments.

Conditions

  • Actinic Keratosis

Interventions

DRUG

Ingenol mebutate Picato® and MAL PDT day 1, day 5

Treatment of ingenol mebutate, Picato® 0.015% topical gel applied on day 1 followed by MAL PDT on day 5

DRUG

Ingenol mebutate Picato® day 2, 3, 4

Full treatment course with Ingenol mebutate (Picato®) 0.015% topical gel, apply day 2,3 and 4

PROCEDURE

MAL PDT day 5

Methyl aminolevulate combined with Photodynamic therapy at day 5

Sponsors & Collaborators

  • LEO Pharma

    collaborator INDUSTRY

  • Pacific Dermaesthetics

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2019-12-31
Completion
2019-12-31

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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 NCT02354391 on ClinicalTrials.gov