Photodynamic Treatment of Actinic Keratoses With Different Light Doses

NCT01541228 | Completed DMC

• 1 other identifier: BE-2-60
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study: To evaluate clinical effectiveness of two different light doses when treating actinic keratoses with photodynamic therapy with 20% 5-aminolevulinic acid.

Conditions

Actinic Keratosis

Keywords

actinic keratosis; photodynamic therapy; 5-aminolevulinic acid

Outcome Measures

Primary Outcomes (1)

• Clinically cleared actinic keratosis with histological evaluation when clinically suspicious for relapse

  All treated actinic keratoses evaluated by two investigators for clinical/histological relapse at months 1, 3, 6, 12, 24 after treatment

  3 months

Secondary Outcomes (1)

• Pain during the treatment

  2 years

Study Arms (2)

Group I

ACTIVE COMPARATOR

Patients with actinic keratosis (AK) on the left and right sides of face/scalp region treated with photodynamic therapy using 20% 5-aminolevulinic acid.

Device: Photodynamic therapy with light dose of 70 J/cm2 using a broad-band red light source

Group II

ACTIVE COMPARATOR

Patients with actinic keratosis (AK) on the left and right sides of the face/scalp region treated with photodynamic therapy using 20% 5-aminolevulinic acid.

Procedure: Photodynamic therapy with 100J/cm2 light dose using a broad-band red light source

Interventions

Photodynamic therapy with light dose of 70 J/cm2 using a broad-band red light source DEVICE

Patients take part in intraindividual (left-right) comparison study when having at least 2 non-hyperkeratotic actinic keratoses (AK) on the left and right sides of the face/scalp. Punch biopsies in 3.5 millimetres diameter performed to confirm the diagnosis of AK. Patients randomized so that half of them would receive a light dose of 70J/cm2 as their first split face/scalp treatment on the left side. Photodynamic therapy with the light dose of 70 J/cm2 using a broad-band red light source (570-670 nm,Curelight®, PhotoCure, Oslo, Norway) and 20% 5-ALA. Treatment repeated twice with two weeks interval.

Group I

Photodynamic therapy with 100J/cm2 light dose using a broad-band red light source PROCEDURE

Patients take part in intraindividual (left-right) comparison study when having at least 2 non-hyperkeratotic actinic keratoses (AK) on the left and right sides of the face/scalp. Punch biopsies in 3.5 millimetres diameter performed to confirm the diagnosis of AK. Patients randomized so that half of them would receive a light dose of 100J/cm2 as their first split face/scalp treatment on the left side. Photodynamic therapy with the light dose of 70 J/cm2 using a broad-band red light source (570-670 nm,Curelight®, PhotoCure, Oslo, Norway) and 20% 5-ALA.Treatment repeated twice with two weeks interval.

Group II

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject older than 50 years.
• Subject has to read Patient Information Sheet and read and sign the Informed Consent form prior to any study related procedure.
• AK with the largest diameter ≤3 cm (measuring the longest axis).
• or more AK with symmetrical distribution on the face or scalp.
• Clinically and histologically confirmed AK of grade I or II.
• Subject must be willing and capable of cooperating to the extent and degree required by the protocol.
• Patient is not the subject of the administrative or legal judicial proceeding.
• Subject has social health security required by laws of health care institutions.

You may not qualify if:

• Patients with more than 5 AK in the planned treatment area.
• A recurrent AK: AK that has been previously treated in the study area.
• Very hyperkeratotic, grade 3 (on a 0-3 scale) AK lesions among the target lesions.
• AK located on the nose.
• Other skin lesions (diseases) in the tumor study area.
• Subject with known hereditary basal cell carcinoma syndromes (Gorlin-Goltz, Basex-Dupre-Christol et al.).
• Subject with a history of cutaneous photosensitization or porphyria or Xeroderma pigmentosum, hypersensitivity to porphyrins, or photodermatosis.
• Subject who had received photosensitizing drugs 30 days before study start.
• Subjects who had received immunomodulatory or immunosuppressive therapies, including systemic and topical steroids, imiquimod or solaraze, interferon and acitretin 6 months prior to study treatment initiation.
• Subject who had participated in another investigational drug or device research study within 30 days of enrolment.
• Subject had received in the study area laser resurfacing, chemical peels, topical application fluorouracil or other drugs for the treatment of AKs within 2 months before study entry.
• Subject with known hypersensitivity to 5-aminolevulinc acid, a similar compound or excipients of the cream.
• Subject with known status after organ transplantation.

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead

Study Sites (1)

Department of Skin and Venereal Diseases, Lithuanian University of Health Sciences, Medical Academy

Kaunas, Eiveniu Saint 2, LT-50009, Lithuania

Location

Related Publications (1)

• Buinauskaite E, Zalinkevicius R, Buinauskiene J, Valiukeviciene S. Pain during topical photodynamic therapy of actinic keratoses with 5-aminolevulinic acid and red light source: randomized controlled trial. Photodermatol Photoimmunol Photomed. 2013 Aug;29(4):173-81. doi: 10.1111/phpp.12044.

  PMID: 23815349 RESULT

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Evelina Buinauskaite, MD

  Lithuanian University of Health Sciences, Medical Academy, Department of Skin and Venereal Diseases

  PRINCIPAL INVESTIGATOR

• Skaidra Valiukeviciene, Prof.

  1Lithuanian University of Health Sciences, Medical Academy, Department of Skin and Venereal Diseases

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: February 29, 2012
• Study Start: April 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2013
• Last Updated: September 4, 2013

Record last verified: 2013-09

Locations

LI (1)