Trial of Methyl Aminolevulinate Plus Aktilite in Facial Photodamage

• 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 ]

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.

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.

• Other: Moisturizer
  Cetaphil cream(For 3 hours) + Aktilite ( Photodynamic Therapy for 8 minutes)
  Other Name: Cetaphil
• Drug: Methyl Aminolevulinate
  Methyl Aminolevulinate cream for 3 hours before Photodynamic therapy ( Aktilite)
  Other Name: Metvix

• Active Comparator: A
  Intervention: Drug: Methyl Aminolevulinate
• Placebo Comparator: B
  Intervention: Other: Moisturizer

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.