NCT00304239

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_3

Geographic Reach
2 countries

11 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

Study Start

First participant enrolled

March 13, 2006

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 16, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2007

Completed
16.5 years until next milestone

Results Posted

Study results publicly available

July 3, 2023

Completed
Last Updated

July 3, 2023

Status Verified

August 1, 2022

Enrollment Period

11 months

First QC Date

March 16, 2006

Results QC Date

August 3, 2022

Last Update Submit

August 3, 2022

Conditions

Actinic Keratosis

Keywords

Methyl aminolevulinatePhotodynamic therapyAktilite CL128 LED light sourceMultiple Actinic Keratosis

Outcome Measures

Primary Outcomes (1)

  • Participant Complete Response Rate (CRR)

    Participant complete response rate was defined as the percentage of participants with complete response. Complete response was defined as the complete disappearance of the lesion determined by clinical assessment (visual inspection and palpation) by an investigator.

    At Week 13

Secondary Outcomes (2)

  • Lesion Complete Response Rate

    At Week 13

  • Number of Participants With at Least One Treatment Site Adverse Events

    From start of study drug administration up to Week 13

Study Arms (2)

Metvix-PDT

EXPERIMENTAL

Participants received Metvix-PDT (methyl aminolevulinate hydrochloride-Photodynamic therapy) 160 milligrams per gram (mg/g) cream on face and/or scalp for 3 hours on Day 0 and Day 7.

Combination Product: Metvix-PDT

Vehicle-PDT

PLACEBO COMPARATOR

Participants received Vehicle cream (Vehicle-PDT) on face and/or scalp for 3 hours on Day 0 and Day 7.

Combination Product: Vehicle-PDT

Interventions

Metvix-PDTCOMBINATION_PRODUCT

Metvix 160 mg/g Cream was applied for 3 hours with occlusive dressing, and illumination with non-coherent red light using the Aktilite CL128 lamp, with a total light dose 37 Joule/square centimeter (J/cm²). All eligible lesions on the participant were treated twice with an interval of 1 week between treatments.

Metvix-PDT
Vehicle-PDTCOMBINATION_PRODUCT

Vehicle Cream was applied for 3 hours with occlusive dressing, and illumination with non-coherent red light using the Aktilite CL128 lamp, with a total light dose 37 J/cm². All eligible lesions on the participant were treated twice with an interval of 1 week between treatments.

Vehicle-PDT

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:

  • Participants with porphyria.
  • Participants immunosuppressed for idiopathic, disease specific or therapeutic reasons.
  • Known allergy to MAL, a similar PDT compound or excipients of the cream.
  • Participants 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.
  • Participants receiving local treatment (including cryotherapy and curretage) in face / scalp area within the last 30 days.
  • Participants 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.
  • Participants currently receiving regular ultraviolet radiation therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Ashish C. Bhatia

Naperville, Illinois, 60563, United States

Location

Joseph Fowler

Louisville, Kentucky, 40202, United States

Location

Robert T. Matheson

Portland, Oregon, 97223, United States

Location

Steven A. Davis

San Antonio, Texas, 78229, United States

Location

Hautklinik Heinrich Heine Universität

Düsseldorf, 40223, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universität Frankfurt am Main

Frankfurt, 60590, Germany

Location

Praxis Dr. Winfried Klövekorn

Gilching, 82205, Germany

Location

Klinik für Dermatologie und Venerologie Universitätsklinikum Schleswig-Holstein, Campus Lübeck

Lübeck, 23538, Germany

Location

Klinikum der Universität München, Klinikum und Poliklinik für Dermatologie und Allergologie

München, 80337, Germany

Location

Klinik und Poliklinik für Dermatologie, Klinikum der Universität Regensburg

Regensburg, 93053, Germany

Location

Praxis Dr. Klemm

Tutzing, 82327, Germany

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

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Limitations and Caveats

Limitations of the trial such as small numbers of participants analysed or technical problems leading to unreliable data.

Results Point of Contact

Title
Clinical Operations
Organization
Galderma
Clinical.Studies@galderma.com
817 961 5000

Study Officials

  • Rolf M Szeimies, Professor

    Klinik und Poliklinik für Dermatologie, Klinikum der Universität Regensburg

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Double blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2006

First Posted

March 17, 2006

Study Start

March 13, 2006

Primary Completion

January 23, 2007

Study Completion

January 23, 2007

Last Updated

July 3, 2023

Results First Posted

July 3, 2023

Record last verified: 2022-08

Locations

US(4)DE(7)