Efficacy of AFL-assisted PDT in Microinvasive Squamous Cell Carcinoma

NCT02666534 | Completed Phase 1

• 1 other identifier: DAUderma-05
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Surgical excision is the standard treatment for cutaneous SCC. However, many patients diagnosed with SCC are elderly and ineligible for surgery. Ablative fractional laser- assisted photodynamic therapy (AFL-PDT) offered a higher efficacy than conventional Methylaminolevulinate (MAL)-PDT.

Conditions

Microinvasive Squamous Cell Carcinoma

Keywords

Ablative fractional laser; microinvasive squamous cell carcinoma; photodynamic therapy

Outcome Measures

Primary Outcomes (3)

• Difference of short-term complete response (CR) rate between AFL-PDT and MAL-PDT

  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

  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

  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 Outcomes (1)

• Difference of the cosmetic outcome between AFL-PDT and MAL-PDT

  Cosmetic outcome was assessed by each investigator for all lesions that achieved a complete response at 24 months

Other Outcomes (1)

• Differences of Adverse events(erythema, burning sensation, swelling, bleeding) between AFL-PDT and MAL-PDT

  Within 24 months after each treatment

Study Arms (2)

AFL-PDT

EXPERIMENTAL

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)

Drug: lidocaine-prilocaine 5% cream application; Device: 2940-nm Er:YAG AFL pretreatment; Drug: methyl-aminolevulinate application; Device: Illuminating using red light-emitting diode lamps

MAL-PDT

ACTIVE COMPARATOR

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)

Drug: methyl-aminolevulinate application; Device: Illuminating using red light-emitting diode lamps

Interventions

lidocaine-prilocaine 5% cream application DRUG

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

AFL-PDT

2940-nm Er:YAG AFL pretreatment DEVICE

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

AFL-PDT

methyl-aminolevulinate application DRUG

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.

AFL-PDT; MAL-PDT

Illuminating using red light-emitting diode lamps DEVICE

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.

AFL-PDT; MAL-PDT

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Dong-A University: lead

Study Sites (1)

Dong-A University

Busan, Dong Dae Sin-dong, Seo-gu, 602-715, South Korea

Location

Related Publications (1)

• Choi SH, Kim KH, Song KH. Effect of Methyl Aminolevulinate Photodynamic Therapy With and Without Ablative Fractional Laser Treatment in Patients With Microinvasive Squamous Cell Carcinoma: A Randomized Clinical Trial. JAMA Dermatol. 2017 Mar 1;153(3):289-295. doi: 10.1001/jamadermatol.2016.4463.

  PMID: 28199463 DERIVED

MeSH Terms

Interventions

Lidocaine, Prilocaine Drug Combination

Intervention Hierarchy (Ancestors)

Lidocaine; Acetanilides; Anilides; Amides; Organic Chemicals; Prilocaine; Aniline Compounds; Amines; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: January 28, 2016
• Study Start: January 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 28, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)