Transepidermal Application of Metilaminolevulinate in Daylight PDT in the Treatment of Photodamaged Skin
Condition: Skin Diseases
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      Chronic sun exposure enhances the incidence of cutaneous neoplasms (NMSC - non melanoma skin
      cancer), wrinkles, roughness, telangiectasia and irregular pigmentation of the skin.
      Nowadays, actinic keratosis (AK) are considered in situ squamous cell carcinoma (SCC), and
      should be managed that way. Conventional topical Photodynamic therapy (PDT) has proven its
      efficacy on treatment of AK and cancerization field. PDT's action in global improvement of
      photodamaged skin, texture, pigmentation and reduction of wrinkles has been well documented
      in literature. Immunohistochemical and histopathological essays describe the hypothesis of
      conventional PDT's mechanisms of action in photoaging by dermal remodeling, with enhancement
      of collagen, statiscally significant. Daylight-Photodynamic Therapy (DL-PDT) is a new
      modality that keeps the efficacy of topical PDT in treatment of AK and cancerization field,
      but painless and more practically. Until this moment, there is no report of DL-PDT efficacy
      on photorejuvenation and actinic keratosis evaluated by clinical, histopathological and
      immunohistochemical studies. The investigator's aim is to evaluate the alterations induced by
      isolated DLPDT or DLPDT associated with other techniques of transepidermal drug delivery
      (microneedles, CO2 laser and microdermabrasion) in the treatment of field cancerization in
      photodamaged skin with actinic keratosis, through clinical evaluation, histopathological and
      immunohistochemical studies. It is an interventional, prospective, randomized controlled,
      parallels-groups, four-arm trial with 1:1 allocation ratio study performed in forty patients
      attended at the Dermatology Service of Hospital Universitário Antonio Pedro- Universidade
      Federal Fluminense.
    

Detailed description: 
      This is a randomized controlled, parallels-groups, four-arm trial with 1:1 allocation ratio
      study on the clinical, histological and immunohistochemical changes induced by
      Daylight-Photodynamic Therapy (DL-PDT) in 40 patients presenting face-photodamaged skin with
      actinic keratosis, attended at the Dermatology outpatient clinic of Hospital Antônio Pedro
      (HUAP) of Universidade Federal Fluminense - UFF, who meet the inclusion criteria and agree to
      sign the informed consent form (TCLE) for participation in clinical research. There will be
      four treatment groups with different protocols. These protocols were chosen by hand draw
      using two boxes containing folded papers. One with the 4 numbers of the groups (1, 2, 3, 4),
      and another with 4 papers with the names of the protocols. At each draw, one paper from each
      box was withdrawn, and the combined results from the two boxes defined the treatments of each
      group. Group I was randomly selected to be DL-PDT alone (standard procedure - group control);
      Group II was randomly selected to be DL-PDT with TED (microneedles); Group III was randomly
      selected to be DL-PDT with TED (CO2 laser) and Group IV was was randomly selected to be
      DL-PDT with TED (microdermabrasion with crystal peeling). Two treatment sessions will be
      performed with a 4-week interval, regardless of the protocol chosen per group. Patients will
      be numbered according to the registration for participation in the study. These numbers will
      be distributed in 4 groups randomly through the computer, using an Apple application called
      Random (random number generator: seller Mireia Lluch Ortoloa, category utilities, version 1).
      Each DL-PDT session will consist of: superficial skin curettage all face with a
      dermatological curette; application of pure chemical sunscreen for 15 minutes; application of
      methyl-aminolevulinate (Metvix®, GALDERMA), approved by ANVISA under Registration No.
      1291600650016, for 30 minutes without occlusion, before exposure to daylight for 2 hours.
      Regarding the association of techniques, these will be varied according to the group. For
      clinical evaluation, patient data will be recorded on the evaluation form, and photographs
      with the same position and lighting patterns will be performed before and after predetermined
      periods. For histological and immunohistochemical evaluations, skin biopsies will be
      performed before and after 3 months of the last treatment session.
    

Intervention name(s): Group I (Standard DL-PDT); Group II (DL-PDT with microneedles); Group III (DL-PDT with CO2 laser); Group IV (DL-PDT with microdermabrasion)
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Daylight photodynamic therapy with photosensitizer (MAL - Metvix, Galderma ®); Daylight photodynamic therapy with photosensitizer (MAL - Metvix, Galderma ®) and Microneedles - motorized pen with a tip of 17 grouped needles with 0,5mm (Dermapen Beauty®- Korea) as a techniques of transepidermal drug delivery (TED); Daylight photodynamic therapy with photosensitizer (MAL - Metvix, Galderma ®) and Ablative Fractional Laser (AFXL), CO2 laser, roller-type ferrule, composed of one row with seven fractionating pins (7x1), 60 W, 15 mJ/pixel, 125μm/pixel, 2 mm spacing between ablation zones, density <1% (Pixel Alma Lasers ®) was applied, single-pass; Daylight photodynamic therapy with photosensitizer (MAL - Metvix, Galderma ®) and Microdermabrasion - aluminum oxide crystal (Pan Eletronic®) as a techniques of transepidermal drug delivery (TED)
Other intervention name(s): Daylight PDT; Daylight PDT with microneedles; Daylight PDT with CO2 laser; Daylight PDT with microdermabrasion
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Transepidermic Application of Metilaminolevulinate in Daylight Photodynamic Therapy in the Treatment of Photodamaged Skin
Masking: None (Open Label)
Primary purpose: Treatment