Actinic Keratoses Treatment With Metvix® in Combination With Light

Actinic Keratoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02373371
• Other study ID #: I14034
• Status: Completed
• Phase: Phase 3
• Start date: March 25, 2015
• Est. completion date: June 1, 2018

Study information

• Verified date: August 2018
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 in subjects with mild actinic keratoses (intra-individual comparison)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 1, 2018
• Est. primary completion date: November 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female above 18 years;

• Subject with clinical diagnosis of mild Actinic Keratosis (AK) on the face or the scalp with or without clinical diagnosis of moderate AK on the target areas (TAs);

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Intervention

Drug:
• Metvix®

Procedure:
• Photodynamic Therapy Blue light
Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug
• Photodynamic Therapy Daylight
Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug

Locations

Country	Name	City	State
France	Limoges University Hospital	Limoges

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Limoges	Galderma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Total Number of Treated Mild Lesions Per Side at Week 12	The number of lesions is assessed at baseline (before treatment) and 12 weeks later.; The difference in lesions is recorded for each patient. The mean of disappeared lesions are then calculated for all patients.	Baseline and Week 12
Secondary	Pain Assesment	Pain assesment with a VAS Pain scale; Visual analog scale [VAS] is a continuous scale comprised of a horizontal scale of 10 cm length . The scale is anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 10).	at inclusion (after treatment)
Secondary	Lesions Disappearance Rate at 1 Months From Baseline.	The number of lesions is assessed at baseline (before treatment) and 1 month later.; The difference in lesions is recorded for each patient. The rate is the quotient: " difference in lesions between baseline and at 1 month "/nubmer of lesions at baseline	0(baseline),1 month
Secondary	Lesions Disappearance Rate at 6 Months From Baseline.	The number of lesions is assessed at baseline (before treatment) and 6 month later.; The difference in lesions is recorded for each patient. The rate is the quotient: " difference in lesions between baseline and at 6 month "/nubmer of lesions at baseline	0(baseline), 6 month