Skin DiseasesNCT03963765
Transepidermal Application of Metilaminolevulinate in Daylight PDT in the Treatment of Photodamaged Skin
A study testing Group I (Standard DL-PDT), Group II (DL-PDT with microneedles) and Group III (DL-PDT with CO2 laser) in people with Skin Diseases, run by Universidade Federal Fluminense at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Diseases
- What is being tested?
- Group I (Standard DL-PDT), Group II (DL-PDT with microneedles) and Group III (DL-PDT with CO2 laser)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Feb 2017to 1 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both gender;
- Fitzpatrick phototypes I - IV;
- age between 40 and 75 years;
- photodamaged skin with at least 1 lesion of actinic keratosis
Who cannot join
- Pregnancy and lactation;
- photosensitivity;
- smoking;
- malignant neoplasms;
- infections;
- immunosuppression;
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Universitário Antonio Pedro - Universidade Federal Fluminense
Niterói, Rio de Janeiro, 24070-035
About this study
Official title: Transepidermal Application of Metilaminolevulinate in Daylight Photodynamic Therapy in the Treatment of Photodamaged Skin
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.
Read the 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.
- Conditions
- Skin Diseases
- Being tested
- Group I (Standard DL-PDT), Group II (DL-PDT with microneedles), Group III (DL-PDT with CO2 laser), Group IV (DL-PDT with microdermabrasion)
- Medical subject headings
- Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group I (Standard DL-PDT)Procedure or surgery
Also called Daylight PDT
Daylight photodynamic therapy with photosensitizer (MAL - Metvix, Galderma ®)
Group II (DL-PDT with microneedles)Procedure or surgery
Also called Daylight PDT with microneedles
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)
Group III (DL-PDT with CO2 laser)Procedure or surgery
Also called Daylight PDT with CO2 laser
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
Group IV (DL-PDT with microdermabrasion)Procedure or surgery
Also called Daylight PDT with microdermabrasion
Daylight photodynamic therapy with photosensitizer (MAL - Metvix, Galderma ®) and Microdermabrasion - aluminum oxide crystal (Pan Eletronic®) as a techniques of transepidermal drug delivery (TED)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Group IV (DL-PDT with microdermabrasion) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Secondary outcomes (3)
Histological evaluation: Routine stain - haematoxylin and eosin
Morphologic study: the aspect of the corneal layer and epidermis, the thickness of the epidermis (distance between granular layer and basal layer), the extension of the keratinocytes atypia, the amount and cytological aspect of melanocytes, the thickness of the subepidermal collagen (distance between membrane basal and onset of solar elastosis in the papillary dermis), distribution of solar elastosis (diffuse or compact distribution), the presence and the type of inflammatory infiltrate, the presence or absence of ectasia in the papillary dermis vessels. These measurements were performed through an ocular lens with a millimeter ruler (Olympus).
Measured: 1 year
Histological evaluation: Special stains (Orcein and Picrosirius)
Orcein (morphologic study): the distribution of solar elastosis and the organization of the elastic fibers (elaunin and oxytalan fibers present in the papillary dermis and dermo-epidermal junction).
Picrosirius (morphometry of dermis collagen)
Measured: 1 year
Immunohistochemistry: epidermis and dermis
Expression of these substrates:
Ki 67, P53 (wild type and mutated): percentage and extent (1/3, 2/3 or 3/3) in the epidermis
Collagen type I and III, MMP 1,3,9, TIMP 1: semiquantitative method: 0, absence of expression; +, weak expression; ++, moderate expression; +++, strong expression.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start3 Feb 2017
- Primary completion5 Dec 2018
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Transepidermic Application of Metilaminolevulinate in Daylight Photodynamic Therapy in the Treatment of Photodamaged Skin
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal Fluminense
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Claudia Almeida Issa, Universidade Federal Fluminense
- Investigators
- Maria Claudia Issa, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963765
- Sponsor's protocol ID
- Daylight PDT
- Status last verified
- Jan 2021
- First submitted
- 23 Apr 2019
- Last updated
- 19 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bento CO, Pantaleao L, Filho PJS, Luiz RR, Gismondi RAOC, Issa MCA. Daylight Photodynamic Therapy Alone or Combined With Transepidermal Drug Delivery Techniques for Skin Field Cancerization: An Immunohistochemical Study of Epidermal Carcinogenesis and Dermal Remodeling Markers. Photodermatol Photoimmunol Photomed. 2026 Nov;42(6):e70124. doi: 10.1111/phpp.70124.
PubMed 42850801
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transepidermal Application of Metilaminolevulinate in Daylight Photodynamic Therapy in the Treatment of Photodamaged Skin
- ClinicalTrials.gov ID
- NCT03963765
- Acronym / sponsor ID
- Daylight PDT
- Conditions
- Skin Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade Federal FluminenseUniversity, hospital or other
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 5 Dec 2018 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 28 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Transepidermic Application of Metilaminolevulinate in Daylight Photodynamic Therapy in the Treatment of Photodamaged Skin
| Arm | Type | Receives |
|---|---|---|
| Group I (Standard DL-PDT) | Active comparator | Procedure: Group I (Standard DL-PDT)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. |
| Group II (DL-PDT with microneedles) | Experimental | Procedure: Group II (DL-PDT with microneedles)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. |
| Group III (DL-PDT with CO2 laser) | Experimental | Procedure: Group III (DL-PDT with CO2 laser)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. |
| Group IV (DL-PDT with microdermabrasion) | Experimental | Procedure: Group IV (DL-PDT with microdermabrasion)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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both gender;
- Fitzpatrick phototypes I - IV;
- age between 40 and 75 years;
- photodamaged skin with at least 1 lesion of actinic keratosis
Key exclusion criteria (9 listed)
- Pregnancy and lactation;
- photosensitivity;
- smoking;
- malignant neoplasms;
- infections;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group I (Standard DL-PDT)Also: Daylight PDTDaylight photodynamic therapy with photosensitizer (MAL - Metvix, Galderma ®) | Procedure or surgery | Group I (Standard DL-PDT) |
| Group II (DL-PDT with microneedles)Also: Daylight PDT with microneedlesDaylight 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) | Procedure or surgery | Group II (DL-PDT with microneedles) |
| Group III (DL-PDT with CO2 laser)Also: Daylight PDT with CO2 laserDaylight 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 | Procedure or surgery | Group III (DL-PDT with CO2 laser) |
| Group IV (DL-PDT with microdermabrasion)Also: Daylight PDT with microdermabrasionDaylight photodynamic therapy with photosensitizer (MAL - Metvix, Galderma ®) and Microdermabrasion - aluminum oxide crystal (Pan Eletronic®) as a techniques of transepidermal drug delivery (TED) | Procedure or surgery | Group IV (DL-PDT with microdermabrasion) |
Primary outcome
Quantitative clinical evaluation of Actinic keratoses
Time frame: 6 months
Numbers of Actinic keratoses on the face: count of lesions before treatment and one month/three months/six months after the second session.
Qualitative clinical evaluation of Actinic keratoses
Time frame: 6 months
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.
Qualitative evaluation of global clinical skin change
Time frame: 6 months
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.
3 secondary outcomes
Histological evaluation: Routine stain - haematoxylin and eosin
Time frame: 1 year
Histological evaluation: Special stains (Orcein and Picrosirius)
Time frame: 1 year
Immunohistochemistry: epidermis and dermis
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2021.
- Derived from this study: PubMed 42850801Bento CO, Pantaleao L, Filho PJS, Luiz RR, Gismondi RAOC, Issa MCA. Daylight Photodynamic Therapy Alone or Combined With Transepidermal Drug Delivery Techniques for Skin Field Cancerization: An Immunohistochemical Study of Epidermal Carcinogenesis and Dermal Remodeling Markers. Photodermatol Photoimmunol Photomed. 2026 Nov;42(6):e70124. doi: 10.1111/phpp.70124.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Claudia Issa principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group I (Standard DL-PDT), Group II (DL-PDT with microneedles) and Group III (DL-PDT with CO2 laser) in people with Skin Diseases, run by Universidade Federal Fluminense at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative clinical evaluation of Actinic keratoses (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03963765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jan 2021.