Trial of Methyl Aminolevulinate Plus Aktilite in Facial P... | NCT00629317

Studies
Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage

NCT00629317

Sponsor

Universidad de Antioquia

Status

Completed

Last Update Posted

Mar 16, 2009Estimated

Enrollment

49Actual

Phase

Phase 3

Conditions

Skin Aging

Interventions

Moisturizer
Methyl Aminolevulinate

Countries

Colombia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Mar 2009Actual

First Submitted Date

Feb 25, 2008

First Submission Date that Met QC Criteria

Mar 4, 2008

First Posted Date

Mar 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2009

Last Update Posted Date

Mar 16, 2009Estimated

Name	Class
Galderma R&D	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

49Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A	Active Comparator		Drug: Methyl Aminolevulinate
B	Placebo Comparator		Other: Moisturizer

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Moisturizer	Other	Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes)	B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy in facial global photodamage		8 months

Secondary Outcomes

Measure	Description	Time Frame
Facial fine lines, mottled pigmentation, tactile roughness, sallowness, erythema, telangiectasia		12 months
Histological effect of MAL+PDT in fibrosis and new collagen formation		12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IPS Universitaria - Universidad de Antioquia		Medellín	Antioquia	01	Colombia

Intervention Browse Module

MeSH Terms

ID	Term
C011189	cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion
C475457	methyl 5-aminolevulinate

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided