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

NCT ID: NCT02354391

Last Updated: 2019-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2019-12-31

Brief 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.

Detailed Description

Study Objective 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). This test area will be compared to Picato® treatment alone or MAL PDT alone treatment areas as well as a control field (no treatment).

Rationale This study focuses on the topical treatment of actinic keratosis. 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. Patients will be followed through appointments with the study nurse and dermatologist.

Patient treatment eligibility and regimen for prescribed medication are at Dr. Rivers (and patient's) discretion. Patients will be followed in the study for the duration of one complete treatment plus 2 months.

Study duration:

The inclusion period is 6 months, depending on the speed of patient recruitment. The study duration for each individual patient will end eight weeks after treatment completion.

Conditions

Actinic Keratosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ingenol mebutate and MAL PDT

Participants will recieve Ingenol mebutate 0.015% topical gel treatment applied day 2,3 and 4 to quadrant 1. Patients will recieve ingenol mebutate 0.015% applied on day 1 followed by methyl aminolevulate and photodyamnic therapy on day 5 to quadrant 2. Particpants will recieve methyl aminolevulate and photodynamic therapy on day 5 to quadrant 3, and quadrant 4 will act as the control, with no treatment.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Ingenol mebutate Picato® day 2, 3, 4

Intervention Type: DRUG

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

MAL PDT day 5

Intervention Type: PROCEDURE

Methyl aminolevulate combined with Photodynamic therapy at day 5

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

MAL PDT day 5

Methyl aminolevulate combined with Photodynamic therapy at day 5

Intervention Type: PROCEDURE

Other Intervention Names

Picato® 0.015% and MAL PDT; Picato® 0.015%; MAL PDT

Eligibility Criteria

Inclusion Criteria

1. Age > 40 yrs

2. Patients eligible to receive topical treatment with ingenol mebutate gel and photodynamic therapy for treatment of actinic keratosis at the discretion of the dermatologist.

3. Fitzpatrick Skin Type I & II.

4. Patient must give informed consent.

Exclusion Criteria

1. Diagnosis of Basal Cell Carcinoma(BCC), Squamous Cell Carcinoma(SCC) or melanoma in the treatment area.

2. Currently experiencing adverse reactions and/or Local Skin Reactions from previous Actinic Keratosis(AK) treatment in the treatment field.

3. Females who are pregnant, nursing or planning a pregnancy during their participation in the study.

4. Female subjects of childbearing potential (including subjects using surgical sterilization, ie, bilateral tubal ligation or implanted device methods of contraception) with a positive urine pregnancy test at Day 1 prior to study treatment; a female is considered NOT to be of childbearing potential if she is post-menopausal with at least 12 consecutive months of amenorrhea, has undergone bilateral oophorectomy, or has no uterus.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: collaborator

Pacific Dermaesthetics

OTHER

Sponsor Role: lead

Responsible Party

Jason K Rivers, MD, FRCPC, FAAD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

1969699

Identifier Type: -

Identifier Source: org_study_id