Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage - Full Text View

Sponsor:	Universidad de Antioquia
Collaborator:	Galderma
Information provided by:	Universidad de Antioquia
ClinicalTrials.gov Identifier:	NCT00629317

Purpose

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.

Condition	Intervention	Phase
Skin Aging	Other: Moisturizer Drug: Methyl Aminolevulinate	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Trial of Methyl Aminolevulinate + Aktilite in Patients With Facial Photodamage

Resource links provided by NLM:

MedlinePlus related topics: Skin Aging

Drug Information available for: Methyl aminolevulinate Aminolevulinic acid Aminolevulinic acid hydrochloride

U.S. FDA Resources

Further study details as provided by Universidad de Antioquia:

Primary Outcome Measures:

Efficacy in facial global photodamage [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Facial fine lines, mottled pigmentation, tactile roughness, sallowness, erythema, telangiectasia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Histological effect of MAL+PDT in fibrosis and new collagen formation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Safety and tolerance [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	49
Study Start Date:	February 2008
Study Completion Date:	March 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A	Drug: Methyl Aminolevulinate Methyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite) Other Name: Metvix
Placebo Comparator: B	Other: Moisturizer Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes) Other Name: Cetaphil

Detailed 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.

Eligibility

Ages Eligible for Study:	35 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629317

Locations

Colombia
IPS Universitaria - Universidad de Antioquia
Medellin, Antioquia, Colombia, 01

Sponsors and Collaborators

Universidad de Antioquia

Galderma

Investigators

Principal Investigator:	Gloria Sanclemente, Dr	Coordinator Group of Investigative Dermatology-GRID
Study Chair:	Hector I Garcia, Dr.	Coordinator GRAEPIC

More Information

No publications provided

Responsible Party:	Gloria Sanclemente, MD, MSc., Universidad de Antioquia
ClinicalTrials.gov Identifier:	NCT00629317 History of Changes
Other Study ID Numbers:	PISUI 2007-031
Study First Received:	February 25, 2008
Last Updated:	March 13, 2009
Health Authority:	Colombia: Institutional Review Board

Keywords provided by Universidad de Antioquia:

Skin Aging
Rejuvenation
Photodynamic Therapy
Methyl Aminolevulinate

Additional relevant MeSH terms:

Aminolevulinic Acid
Methyl 5-aminolevulinate
Photosensitizing Agents
Radiation-Sensitizing Agents

Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 12, 2012