Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage

Skin Aging Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Trial of Methyl Aminolevulinate + Aktilite in Patients With Facial Photodamage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629317
• Other study ID #: PISUI 2007-031
• Status: Completed
• Phase: Phase 3
• First received: February 25, 2008
• Last updated: March 13, 2009
• Start date: February 2008
• Est. completion date: March 2009

Study information

• Verified date: March 2009
• Source: Universidad de Antioquia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to determine the efficacy of MAL + Aktilite versus placebo + Aktilite in facial photodamage in a randomized double blind trial.

Description:

It has been demonstrated that photodamage leads to wrinkles, mottled pigmentation, lentigines, telangiectasias, and textural changes, but more importantly, it can also lead to pre-cancerous conditions with the development of actinic keratosis (AK). The majority of photorejuvenation or photodamaged published studies have used 5-Amino-Levulinic acid (5-ALA) as a photosensitizer, and either a blue light or an Intense Pulsed Light source with a 70%-95% global facial skin improvement. The molecular mechanism of such improvement is unknown, but activation of a non-specific immune response in addition to increased fibrosis and new collagen formation, have both been suggested.

Methyl Aminolevulinate ( MAL) is another marketed photosensitizer mainly utilized in Europe. Lipophilicity, higher penetration depth and tumor selectivity has been advocated for MAL compared to 5-ALA. However, its effect in photodamaged skin has not been well documented.

The aim of the study is to determine the efficacy of MAL + Aktilite (PDT) in facial photodamage.

Study Type: Interventional

Study Design: Randomized, double-Blind, placebo-controlled trial. Official Title: A randomized, double-Blind, placebo-controlled trial of Methyl Aminolevulinate + Aktilite in patients with facial photodamage.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• Female subjects older than 35 years of age and less than 75 years of age

• Subjects with a photodamage grade of 2 or 3 according to a modified Dover´s Global photodamage scale

• Subjects willing to participate according to protocol requirements.

• Patients with signed Informed Consent

• Patients with no exclusion criteria

Exclusion Criteria:

• Pregnant or nursing females.

• Subjects with suspected porphyria, Systemic or cutaneous erythematosus lupus, or any other photosensitizing disorder or drug induced photosensitization.

• Any active infectious skin disorder ( Herpes simplex, molluscum contagiosum, facial warts )

• Subjects with less than 6 months of previous rejuvenation interfering treatments

• Subjects requiring concurrent treatment that would interfere with study objectives and/or assessments.

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Skin Aging

Intervention

Other:
• Moisturizer
Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes)

Drug:
• Methyl Aminolevulinate
Methyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite)

Locations

Country	Name	City	State
Colombia	IPS Universitaria - Universidad de Antioquia	Medellin	Antioquia

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Antioquia	Galderma

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy in facial global photodamage		8 months	No
Secondary	Facial fine lines, mottled pigmentation, tactile roughness, sallowness, erythema, telangiectasia		12 months	Yes
Secondary	Histological effect of MAL+PDT in fibrosis and new collagen formation		12 months	Yes
Secondary	Safety and tolerance		12 months	Yes