NCT02354391

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_2

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

4.9 years

First QC Date

January 20, 2015

Last Update Submit

March 22, 2019

Conditions

Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

  • Complete clearance of lesions

    The proportion of patients with complete clearance of actinic keratoses in the treatment area compared to baseline.

    60 days

Secondary Outcomes (13)

  • Localized skin response to Erythema is measured using a 4 point scale, 0 (no erythema) to 3 (severe erythema)

    Day 5, 8 and 15

  • Count of actinic kertosis lesions

    60 days (day 15, 30 and 60)

  • Localized skin response to Flaking/Scaling is measured using a 4 point scale, 0 (no flaking/scaling) to 3 (severe flaking/scaling)

    Day 5, 8 and 15

  • Localized skin response to Pustulation is measured using a 4 point scale, 0 (no pustulation) to 3 (severe pustulation)

    Day 5, 8 and 15

  • Localized skin response to Vesiculation is measured using a 4 point scale, 0 (no vesiculation) to 3 (severe vesiculation)

    Day 5, 8 and 15

  • +8 more secondary outcomes

Study Arms (1)

Ingenol mebutate and MAL PDT

EXPERIMENTAL

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.

Drug: Ingenol mebutate Picato® and MAL PDT day 1, day 5Drug: Ingenol mebutate Picato® day 2, 3, 4Procedure: MAL PDT day 5

Interventions

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

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

Also known as: Picato® 0.015% and MAL PDT
Ingenol mebutate and MAL PDT
Ingenol mebutate Picato® day 2, 3, 4DRUG

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

Also known as: Picato® 0.015%
Ingenol mebutate and MAL PDT
MAL PDT day 5PROCEDURE

Methyl aminolevulate combined with Photodynamic therapy at day 5

Also known as: MAL PDT
Ingenol mebutate and MAL PDT

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \> 40 yrs
  • Patients eligible to receive topical treatment with ingenol mebutate gel and photodynamic therapy for treatment of actinic keratosis at the discretion of the dermatologist.
  • Fitzpatrick Skin Type I \& II.
  • Patient must give informed consent.

You may not qualify if:

  • Diagnosis of Basal Cell Carcinoma(BCC), Squamous Cell Carcinoma(SCC) or melanoma in the treatment area.
  • Currently experiencing adverse reactions and/or Local Skin Reactions from previous Actinic Keratosis(AK) treatment in the treatment field.
  • Females who are pregnant, nursing or planning a pregnancy during their participation in the study.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

3-ingenyl angelate

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 20, 2015

First Posted

February 3, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

March 26, 2019

Record last verified: 2019-03