NCT00629317

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 16, 2009

Status Verified

March 1, 2009

Enrollment Period

11 months

First QC Date

February 25, 2008

Last Update Submit

March 13, 2009

Conditions

Skin Aging

Keywords

Skin AgingRejuvenationPhotodynamic TherapyMethyl Aminolevulinate

Outcome Measures

Primary Outcomes (1)

  • Efficacy in facial global photodamage

    8 months

Secondary Outcomes (3)

  • 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

  • Safety and tolerance

    12 months

Study Arms (2)

A

ACTIVE COMPARATOR
Drug: Methyl Aminolevulinate

B

PLACEBO COMPARATOR
Other: Moisturizer

Interventions

MoisturizerOTHER

Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes)

Also known as: Cetaphil
B
Methyl AminolevulinateDRUG

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

Also known as: Metvix
A

Eligibility Criteria

Age35 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IPS Universitaria - Universidad de Antioquia

Medellín, Antioquia, 01, Colombia

Location

MeSH Terms

Interventions

cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotionmethyl 5-aminolevulinate

Study Officials

  • Gloria Sanclemente, Dr

    Coordinator Group of Investigative Dermatology-GRID

    PRINCIPAL INVESTIGATOR

  • Hector I Garcia, Dr.

    Coordinator GRAEPIC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2008

First Posted

March 6, 2008

Study Start

February 1, 2008

Primary Completion

January 1, 2009

Study Completion

March 1, 2009

Last Updated

March 16, 2009

Record last verified: 2009-03

Locations

CO(1)