Transepidermal Application of Metilaminolevulinate in Daylight PDT in the Treatment of Photodamaged Skin

NCT03963765 | Completed

• 1 other identifier: Daylight PDT
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Diseases

Outcome Measures

Primary Outcomes (3)

• Quantitative clinical evaluation of Actinic keratoses

  Numbers of Actinic keratoses on the face: count of lesions before treatment and one month/three months/six months after the second session.

  6 months

• Qualitative clinical evaluation of Actinic keratoses

  Actinic keratoses will be classified by degrees of thickness (grades 1, 2 and 3), based on the Olsen scale (J Am Acad Dermatol. 1991 May;24(5 Pt 1):738-43), before treatment and one month/three months/six months after the second session.

  6 months

• Qualitative evaluation of global clinical skin change

  The overall improvement of photodanificated skin was evaluated using the GAIS scale (Global Aesthetic Improvement Scale) which ranges from: 1 = very much improvement; 2 = marked improvement; 3 = improved; 4 = no change; 5 = worse. Also performed before treatment and one month/three months/six months after the second session.

  6 months

Secondary Outcomes (3)

• Histological evaluation: Routine stain - haematoxylin and eosin

  1 year

• Histological evaluation: Special stains (Orcein and Picrosirius)

  1 year

• Immunohistochemistry: epidermis and dermis

  1 year

Study Arms (4)

Group I (Standard DL-PDT)

ACTIVE COMPARATOR

1. Superficial skin curettage all face with a dermatological curette 2. All exposed skin was covered with pure chemical sunscreen 3. After 15 minutes, a uniform layer of methyl-aminolevulinate (MAL) (Metvix®, Galderma- 1g) was applied to the face without occlusion In all protocols, the patients remained indoor for 30 min after procedures and then exposed to daylight in an open environment for 2 hours. After this period, the skin was cleaned with 0.9% saline, and the sunscreen reapplied.

Procedure: Group I (Standard DL-PDT)

Group II (DL-PDT with microneedles)

EXPERIMENTAL

1. Superficial skin curettage all face with a dermatological curette 2. All exposed skin was covered with pure chemical sunscreen 3. After 15 minutes, a uniform layer of methyl-aminolevulinate (MAL) (Metvix®, Galderma- 1g) was applied to the face without occlusion 4. A motorized pen with a tip of 17 grouped needles with 0,5mm (Dermapen Beauty®- Korea) was applied without bleeding In all protocols, the patients remained indoor for 30 min after procedures and then exposed to daylight in an open environment for 2 hours. After this period, the skin was cleaned with 0.9% saline, and the sunscreen reapplied.

Procedure: Group II (DL-PDT with microneedles)

Group III (DL-PDT with CO2 laser)

EXPERIMENTAL

1. Superficial skin curettage all face with a dermatological curette 2. All exposed skin was covered with pure chemical sunscreen 3. After 15 minutes and removing excess sunscreen, 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 4. A uniform layer of methyl-aminolevulinate (MAL) (Metvix®, Galderma- 1g) was applied to the face without occlusion In all protocols, the patients remained indoor for 30 min after procedures and then exposed to daylight in an open environment for 2 hours. After this period, the skin was cleaned with 0.9% saline, and the sunscreen reapplied.

Procedure: Group III (DL-PDT with CO2 laser)

Group IV (DL-PDT with microdermabrasion)

EXPERIMENTAL

1. Superficial skin curettage all face with a dermatological curette 2. Microdermabrasion with aluminum oxide crystal (Pan Eletronic®) was performed after superficial skin curettage. Three passes on the skin in different directions (vertical, horizontal, and oblique) were applied 3. All exposed skin was covered with pure chemical sunscreen 4. After 15 minutes, a uniform layer of methyl-aminolevulinate (MAL) (Metvix®, Galderma- 1g) was applied to the face without occlusion In all protocols, the patients remained indoor for 30 min after procedures and then exposed to daylight in an open environment for 2 hours. After this period, the skin was cleaned with 0.9% saline, and the sunscreen reapplied.

Procedure: Group IV (DL-PDT with microdermabrasion)

Interventions

Group I (Standard DL-PDT) PROCEDURE

Daylight photodynamic therapy with photosensitizer (MAL - Metvix, Galderma ®)

Also known as: Daylight PDT

Group I (Standard DL-PDT)

Group II (DL-PDT with microneedles) PROCEDURE

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)

Also known as: Daylight PDT with microneedles

Group II (DL-PDT with microneedles)

Group III (DL-PDT with CO2 laser) PROCEDURE

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

Also known as: Daylight PDT with CO2 laser

Group III (DL-PDT with CO2 laser)

Group IV (DL-PDT with microdermabrasion) PROCEDURE

Daylight photodynamic therapy with photosensitizer (MAL - Metvix, Galderma ®) and Microdermabrasion - aluminum oxide crystal (Pan Eletronic®) as a techniques of transepidermal drug delivery (TED)

Also known as: Daylight PDT with microdermabrasion

Group IV (DL-PDT with microdermabrasion)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Both gender;
• Fitzpatrick phototypes I - IV;
• age between 40 and 75 years;
• photodamaged skin with at least 1 lesion of actinic keratosis

You may not qualify if:

• Pregnancy and lactation;
• photosensitivity;
• smoking;
• malignant neoplasms;
• infections;
• immunosuppression;
• collagenoses;
• any systemic disease or emotional/psychological disorder that could contraindicate the procedure.
• any topical treatment or interventions for at least three months before the study started

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Hospital Universitário Antonio Pedro - Universidade Federal Fluminense

Niterói, Rio de Janeiro, 24070-035, Brazil

Location

MeSH Terms

Conditions

Skin Diseases

Interventions

Lasers, Gas

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Maria Claudia Issa

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Transepidermic Application of Metilaminolevulinate in Daylight Photodynamic Therapy in the Treatment of Photodamaged Skin

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 28, 2019
• Study Start: February 3, 2017
• Primary Completion: December 5, 2018
• Study Completion: December 1, 2020
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)