Laser and Microdermabrasion Before Photodynamic Therapy for Actinic Keratoses in Field-cancerized Skin

NCT03006185 | Completed Phase 2 Results DMC

• 2 other identifiers: H-160239912015-002331-18
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparison of treatment efficacy and safety of pretreatment with ablative fractional laser versus microdermabrasion combined with large-area photodynamic therapy with methyl aminolevulinate for actinic keratoses

Conditions

Actinic Keratosis; Sun Damaged Skin; Solar Keratosis; Solar Skin Damage

Outcome Measures

Primary Outcomes (1)

• Complete Clearance (%) of Actinic Keratoses (AKs)

  Percentage clearance of baseline actinic keratoses (AKs), determined by the ratio of AK lesions that are clinically resolved 12-15 weeks after treatment compared to the AK number at baseline.

  12-15 weeks post-treatment

Secondary Outcomes (8)

• New Actinic Keratoses (AKs)

  12-15 weeks post-treatment

• Severity of Local Skin Reactions (LSRs)

  Day 3-6 post treatment

• Degree of Sun Damage

  12-15 weeks post-treatment

• Treatment-related Pain

  during treatment (day 0)

• Treatment-related Side Effects

  up to 12-15 weeks post-treatment

Study Arms (1)

Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion

EXPERIMENTAL

WIthin each participant, two 50 cm2 adjacent test areas were randomized to laser or microdermabrasion pretreatment prior to daylight photodynamic therapy.

Device: Ablative Fractional Carbon Dioxide (CO2) Laser; Device: Microdermabrasion

Interventions

Ablative Fractional Carbon Dioxide (CO2) Laser DEVICE

One 50 cm2 test area was randomized to pretreatment using a fractional 2940 nm Er:YAG laser (Joule®; Sciton Inc., Palo Alto, CA, USA). To remove hyperkeratosis, a fully-ablative 4 mm handpiece was optionally applied, followed by a single pass of a fractional Profrax 430 handpiece for all AKs. Subsequent field treatment consisted of a single pass of the Profrax 430 handpiece over the entire test area. Immediately after pretreatment, a 0.5 mm layer of methyl aminolevulinate (Metvix ® cream 16%; Galderma, Paris, France) was applied. After 30 minutes, patients were exposed to 2 hours of ambient daylight, according to approved procedure. After light exposure, cream was wiped off and test areas were covered for the remainder of the day.

Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion

Microdermabrasion DEVICE

Another adjacent 50 cm2 test area was exposed to microdermabrasion using an MD pad with 58.5 µm-diameter particles (Ambu® Skin Prep Pads 2121M; Ambu A/S, Ballerup, Denmark). Lesion-directed treatment consisted of an increasing number of swipes concentrated to AK lesions. During field treatment, multiple swipes were applied in perpendicular directions over the entire test area. Immediately after pretreatment, a 0.5 mm layer of methyl aminolevulinate (Metvix ® cream 16%; Galderma, Paris, France) was applied. After 30 minutes, patients were exposed to 2 hours of ambient daylight, according to approved procedure. After light exposure, cream was wiped off and test areas were covered for the remainder of the day.

Split-Person Design: Ablative Fractional Carbon Dioxide (CO2) Laser vs Microdermabrasion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with two skin areas of at least 50 cm2 with a minimum of 5 actinic keratoses (AKs) grade I-III, chronically sun damaged "field" changes in one of the following anatomical regions: face, scalp, upper chest.
• Patients who have given written informed consent and are believed to be capable of following the study protocol.

You may not qualify if:

• Patients that have within the last month received local treatment in the test areas.
• Pregnant or nursing patients.
• Patients with porphyria
• Patients with skin cancer, keratoacanthoma, or other infiltrating tumors within the test areas.
• Patients with a tendency to develop hypertrophic scars or keloids.
• Patients with a known allergy to Metvix cream
• Patients that are believe unlikely to follow the study protocol.

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Galderma R&D: collaborator

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Lasers

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Emily Wenande
• Organization: Bispebjerg Hospital

emilycathrinew@hotmail.com

+4540505590

Study Officials

• Merete Haedersdal, MD, Dr. Med

  Bispebjerg Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Senior Physician

Study Record Dates

• First Submitted: December 9, 2016
• First Posted: December 30, 2016
• Study Start: August 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: March 1, 2017
• Last Updated: September 28, 2022
• Results First Posted: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share