Intra-individual Comparison of Efficacy and Safety of Metvix® Natural Daylight Photodynamic Therapy Versus Conventional Metvix® Photodynamic Therapy in Subject With Mild Actinic Keratoses

NCT01475071 | Completed Phase 3 Results

• 1 other identifier: RD.03.SPR.29102
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief Summary

The main objective of this study is to compare efficacy and safety of Metvix® natural daylight photodynamic therapy with those of Metvix® conventional photodynamic therapy with Aktilite™ lamp in subjects with mild actinic keratoses (intra-individual comparison).

Conditions

Actinic Keratoses

Outcome Measures

Primary Outcomes (2)

• Lesion Response

  Percent of lesions treated at Baseline, in complete response at Week 12

  Week12

• Pain Score

  Subject self assessment of pain on a scale from 0 (no pain ) to 10 (extreme pain)

  Baseline (during procedure), assessed after procedure

Study Arms (2)

Metvix and daylight

EXPERIMENTAL

Drug: Metvix and natural daylight PDT

Metvix and lamp

ACTIVE COMPARATOR

Drug: Metvix and conventional PDT

Interventions

Metvix and natural daylight PDT DRUG

Methyl aminolevulinate, cream 160mg/g.One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.

Metvix and daylight

Metvix and conventional PDT DRUG

Methyl aminolevulinate, cream, 160mg/g. One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.

Metvix and lamp

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female above 18 years;
• Subject with clinical diagnosis of mild AK on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);

You may not qualify if:

• Subject with clinical diagnosis of at least one severe AK on TAs
• Subject with clinical diagnosis of other skin disease (including non-melanoma skin cancer) on the TAs;
• Subject with pigmented AK on the TAs

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (6)

Galderma Investigational site

Phillip, Australian Capital Territory, Australia

Location

Galderma Investigational Site

Kogarah, New South Wales, Australia

Location

Galderma Investigational site

Sydney, New South Wales, Australia

Location

Galderma Investigational site

Westmead, New South Wales, Australia

Location

Galderma Investigational site

Woolloongabba, Queensland, Australia

Location

Galderma Investigational site

Carlton, Victoria, Australia

Location

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

methyl 5-aminolevulinate

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Cyril Moulin
• Organization: Galderma

cyril.moulin@galderma.com

+33 4 92 38 30 14

Study Officials

• Stephen Shumack

  St George Dermatology and skin Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2011
• First Posted: November 21, 2011
• Study Start: March 1, 2012
• Primary Completion: November 1, 2012
• Study Completion: March 1, 2013
• Last Updated: February 18, 2021
• Results First Posted: April 18, 2016

Record last verified: 2016-03

Locations

AU (6)