- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02666534
Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma
A Randomised Trial Comparing Methyl Aminolaevulinate Photodynamic Therapy With and Without Ablative Fractional Laser Treatment in Patients With Microinvasive Squamous Cell Carcinoma: Results From a 24-month Follow-up
Study Overview
Status
Conditions
Detailed Description
Squamous cell carcinoma (SCC) lesions are potentially metastatic and can be life threatening. Hence, surgical excision is the standard treatment for cutaneous SCC. However, some patients are ineligible for surgery because of their poor general health, concomitant anticoagulant or immunosuppressive therapies, or allergy to local anesthetics.
Photodynamic therapy (PDT) with methylaminolevulinate (MAL) is an innovative treatment modality that has been approved in Europe for the treatment of actinic keratosis, basal cell carcinoma, and Bowen's disease. However, currently, there is insufficient evidence to support the routine use of topical PDT for SCC.
Ablative fractional laser (AFL) ablates the epidermis and dermis without significant thermal injury, creating microscopic ablation zones in the portion of the skin that the laser is applied to. Our previous studies showed that AFL-primed MAL-PDT (AFL-PDT) offered a higher efficacy than conventional MAL-PDT in the treatment of many other diseases, such as actinic keratosis, actinic cheilitis, and Bowen's disease.
Investigators recruited Korean patients with microinvasive SCC and compared the efficacy, recurrence rate, and cosmetic outcomes of AFL-PDT with those of standard MAL-PDT.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Dong dae sin-dong, Seo-gu
-
Busan, Dong dae sin-dong, Seo-gu, Korea, Republic of, 602-715
- Dong-A University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients aged 18 years or more who had previously untreated microinvasive SCC, providing they satisfied both of the following conditions:
- tumor invasion into the papillary dermis (Clark level II) according to a biopsy specimen and
- difficulty in surgical excision because of health problems (bleeding tendency or cardiac problems)
Exclusion Criteria:
- pregnancy or lactation
- active systemic infectious disease
- other inflammatory, infectious, or neoplastic skin diseases in the treated area
- allergy to MAL,other topical photosensitizers, or excipients of the cream
- history of photosensitivity
- use of immunosuppressive or photosensitizing drugs
- participation in any other investigational study in the preceding 30 days
- history or indicators of poor compliance
- Histological findings of acantholysis, desmoplasia, perineural or lymphovascular invasion, and echographic features of regional lymph node metastasis were the disease-specific exclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AFL-PDT
Forty-five Korean patients were enrolled in this study.
Patients were randomly assigned to receive either AFL-PDT or MAL-PDT in a 1:1 ratio.
As result, the patients were randomized to treatment with AFL-PDT (21 patients) or MAL-PDT (24 patients)
|
The lesions were then cleansed with saline gauze, and a lidocaine-prilocaine 5% cream (EMLA®; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area for 30 min under occlusion
After the anesthetic cream was removed, AFL was performed using a 2940-nm Er:YAG AFL (Joule; Sciton, Inc., Palo Alto, CA, USA) with a 500 µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse
Immediately after the AFL, a 1-mm thick layer of methyl-aminolevulinate (16% Metvix® cream; PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of the surrounding healthy tissue.
The area was covered with an occlusive dressing (Tegaderm; 3M, Co., Saint Paul, MN, USA) for 3 h, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light.
Each treatment area was then separately illuminated using red light-emitting diode lamps (Aktilite CL128; Galderma S.A., Bruchsal, Germany) with peak emission at 632 nm and a total light dose of 37 J/cm2.
Areas scheduled to receive MAL-PDT received the second treatment 7 days later.
During the illumination, patients were asked to evaluate pain intensity using an 11-point visual analog scale.
|
Active Comparator: MAL-PDT
Forty-five Korean patients were enrolled in this study.
Patients were randomly assigned to receive either AFL-PDT or MAL-PDT in a 1:1 ratio.
As result, the patients were randomized to treatment with AFL-PDT (21 patients) or MAL-PDT (24 patients)
|
Immediately after the AFL, a 1-mm thick layer of methyl-aminolevulinate (16% Metvix® cream; PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of the surrounding healthy tissue.
The area was covered with an occlusive dressing (Tegaderm; 3M, Co., Saint Paul, MN, USA) for 3 h, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light.
Each treatment area was then separately illuminated using red light-emitting diode lamps (Aktilite CL128; Galderma S.A., Bruchsal, Germany) with peak emission at 632 nm and a total light dose of 37 J/cm2.
Areas scheduled to receive MAL-PDT received the second treatment 7 days later.
During the illumination, patients were asked to evaluate pain intensity using an 11-point visual analog scale.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference of short-term complete response (CR) rate between AFL-PDT and MAL-PDT
Time Frame: Short-term CR rate was evaluated at 3 months
|
The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)
|
Short-term CR rate was evaluated at 3 months
|
Difference of long-term complete response (CR) rate between AFL-PDT and MAL-PDT
Time Frame: Long-term CR rate was evaluated at 24 months
|
The response was classified as either complete response (complete disappearance of the lesion) or incomplete response (incomplete disappearance of the lesion)
|
Long-term CR rate was evaluated at 24 months
|
Difference of recurrence rate at 24 months
Time Frame: Recurrent rate was evaluated at 24months
|
In all cases of complete response, the patients were reviewed at 24 months to check for recurrence.
Post-therapy punch biopsies were performed when there was doubt concerning incomplete-response and clinical recurrence
|
Recurrent rate was evaluated at 24months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference of the cosmetic outcome between AFL-PDT and MAL-PDT
Time Frame: Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 24 months
|
The overall cosmetic outcome was assessed by each investigator for all lesions that achieved complete response at 24 months, and was graded using a 4-point scale: excellent (only slight occurrence of redness or change in pigmentation), good (moderate redness or change in pigmentation), fair (slight to moderate scarring, atrophy, or induration), or poor (extensive scarring, atrophy, or induration)
|
Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 24 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Differences of Adverse events(erythema, burning sensation, swelling, bleeding) between AFL-PDT and MAL-PDT
Time Frame: Within 24 months after each treatment
|
Adverse events reported by the patients were noted at each follow-up visit, including severity, duration, and need for additional therapy.
All events due to PDT were described as phototoxic reactions(e.g
erythema, burning sensation, swelling, bleeding)
|
Within 24 months after each treatment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Photosensitizing Agents
- Dermatologic Agents
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Anesthetics, Combined
- Lidocaine
- Aminolevulinic Acid
- Prilocaine
- Lidocaine, Prilocaine Drug Combination
- Methyl 5-aminolevulinate
Other Study ID Numbers
- DAUderma-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Microinvasive Squamous Cell Carcinoma
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IVA Oral Cavity Squamous Cell Carcinoma | Stage IV Hypopharyngeal Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage IVB Laryngeal Squamous Cell Carcinoma | Stage IVB Oropharyngeal Squamous Cell Carcinoma | Stage... and other conditionsUnited States
-
Emory UniversitySynta Pharmaceuticals Corp.TerminatedStage IVA Oral Cavity Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage IVA Oropharyngeal Squamous Cell Carcinoma | Stage I Hypopharyngeal Squamous Cell Carcinoma | Stage I Laryngeal Squamous Cell Carcinoma | Stage I Oropharyngeal Squamous Cell Carcinoma | Stage II... and other conditionsUnited States
-
National Cancer Institute (NCI)TerminatedRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Stage IVA Oral Cavity Squamous Cell Carcinoma | Stage IVA Laryngeal Squamous Cell Carcinoma | Stage... and other conditionsCanada, United States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)TerminatedRecurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Recurrent Nasopharyngeal Keratinizing Squamous Cell Carcinoma | Stage IVA Oral Cavity Squamous Cell... and other conditionsUnited States
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)CompletedRecurrent Head and Neck Squamous Cell Carcinoma | Recurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Caregiver | Salivary Gland Squamous Cell Carcinoma | Malignant Head and Neck Neoplasm | Recurrent Lip and Oral Cavity Squamous Cell Carcinoma | Stage... and other conditionsUnited States
-
NRG OncologyNational Cancer Institute (NCI)RecruitingAdvanced Head and Neck Squamous Cell Carcinoma | Squamous Cell Carcinoma of Unknown Primary | Advanced Hypopharyngeal Squamous Cell Carcinoma | Advanced Laryngeal Squamous Cell Carcinoma | Advanced Oropharyngeal Squamous Cell CarcinomaUnited States, Canada
-
City of Hope Medical CenterNational Cancer Institute (NCI); Genentech, Inc.RecruitingLocally Advanced Skin Squamous Cell Carcinoma | Unresectable Skin Squamous Cell Carcinoma | Resectable Skin Squamous Cell CarcinomaUnited States
-
Baptist Health South FloridaRegeneron PharmaceuticalsWithdrawnSquamous Cell Carcinoma | Cutaneous Squamous Cell Carcinoma | Advanced Squamous Cell CarcinomaUnited States
-
Hyunseok Kang, MDNeoImmuneTechRecruitingRecurrent Head and Neck Squamous Cell Carcinoma | Recurrent Hypopharyngeal Squamous Cell Carcinoma | Recurrent Laryngeal Squamous Cell Carcinoma | Recurrent Oral Cavity Squamous Cell Carcinoma | Recurrent Oropharyngeal Squamous Cell Carcinoma | Resectable Oropharyngeal Squamous Cell CarcinomaUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteAstraZeneca; Brooklyn ImmunoTherapeutics, LLCActive, not recruitingSquamous Cell Carcinoma of the Head and Neck | Oropharynx Squamous Cell Carcinoma | Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | Metastatic Squamous Cell Carcinoma | Hypopharynx Squamous Cell Carcinoma | Paranasal Sinus Squamous Cell Carcinoma | Larynx Squamous Cell CarcinomaUnited States
Clinical Trials on lidocaine-prilocaine 5% cream application
-
Dong-A UniversityCompleted
-
Dong-A UniversityCompletedActinic DermatosisKorea, Republic of
-
National University Hospital, SingaporeUnknown
-
Beatrice Olsson DuseCompleted
-
Assiut UniversityCompleted
-
Dong-A UniversityCompletedActinic Keratosis
-
Cairo UniversityUnknown
-
Consorci Sanitari de TerrassaCompleted
-
Stanford UniversityWithdrawn