NCT00306800

Brief Summary

The purpose of this study is to compare the efficacy of Photodynamic Therapy (PDT) with methyl aminolevulinate (MAL) cream to PDT with vehicle cream, using the the LED light source Aktilite CL128, in treatment of patients with multiple actinic keratosis (sun-damaged skin) on the face and / or scalp

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

7 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2006

Completed
1.4 years until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

February 18, 2021

Status Verified

September 1, 2010

First QC Date

March 22, 2006

Last Update Submit

February 16, 2021

Conditions

Actinic Keratosis

Keywords

Methyl aminolevulinatePhotodynamic therapyAktilite CL128 LED light sourceMultiple Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

  • Primary: Primary outcome: To compare the patient complete response rate of MAL PDT to that of vehicle PDT 3 months after the last treatment in patients with multiple actinic keratoses on the face and/or scalp

Secondary Outcomes (1)

  • Secondary: The secondary outcomes: To compare local Adverse Events (treatment site Adverse Events (AEs) between MAL PDT and vehicle PDT; To compare the lesion complete response rate between MAL PDT and vehicle PDT 3 months after last treatment

Interventions

Photodynamic therapy with methyl aminolevulinate creamPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of 4-10 previously untreated, not pigmented, non-hyperkeratotic AK lesions of 3 mm or more diameter of Grade 1 and/or 2 of the face and/or scalp where other therapies are unacceptable or considered medically less appropriate.
  • Males or females above 18 years of age.
  • Written informed consent

You may not qualify if:

  • Patients with porphyria.
  • Patients immunosuppressed for idiopathic, disease specific or therapeutic reasons.
  • Known allergy to MAL, a similar PDT compound or excipients of the cream.
  • Patients with history of hypersensitivity to nut products or other known protein antigens.
  • Participation in other clinical studies either currently or within the last 30 days.
  • Patients receiving local treatment (including cryotherapy and curretage) in face / scalp area within the last 30 days.
  • Patients receiving topical treatment (including imiquimod, 5-FU and diclofenac) in face / scalp area within the last 3 months.
  • Pregnant or breast-feeding: All women of child-bearing potential must use adequate contraception (oral contraceptives, intrauterine device, contraceptive skin patch, etc) during the treatment period and one month thereafter. In addition, they must have a negative pregnancy test prior to treatment.
  • Any conditions that may be associated with a risk of poor protocol compliance.
  • Patients currently receiving regular ultraviolet radiation therap

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Spencer Dermatology and Skin Surgery

St. Petersburg, Florida, 33716-1115, United States

Location

Laser and Skin Surgery Center

New York, New York, 10016, United States

Location

Dermatology Associates of Rochester

Rochester, New York, 14623, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Dermresearch Inc

Austin, Texas, 78759, United States

Location

Texas Dermatology Research Institute

Dallas, Texas, 75230, United States

Location

Suzanne Bruce and Associates, PA

Houston, Texas, 77056, United States

Location

Related Publications (2)

  • Pariser DM, Lowe NJ, Stewart DM, Jarratt MT, Lucky AW, Pariser RJ, Yamauchi PS. Photodynamic therapy with topical methyl aminolevulinate for actinic keratosis: results of a prospective randomized multicenter trial. J Am Acad Dermatol. 2003 Feb;48(2):227-32. doi: 10.1067/mjd.2003.49.

    PMID: 12582393BACKGROUND

  • Freeman M, Vinciullo C, Francis D, Spelman L, Nguyen R, Fergin P, Thai KE, Murrell D, Weightman W, Anderson C, Reid C, Watson A, Foley P. A comparison of photodynamic therapy using topical methyl aminolevulinate (Metvix) with single cycle cryotherapy in patients with actinic keratosis: a prospective, randomized study. J Dermatolog Treat. 2003 Jun;14(2):99-106. doi: 10.1080/09546630310012118.

    PMID: 12775317BACKGROUND

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • David Pariser, MD

    Virginia Clinical Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 22, 2006

First Posted

March 24, 2006

Study Start

September 1, 2007

Study Completion

October 1, 2007

Last Updated

February 18, 2021

Record last verified: 2010-09

Locations

US(7)