Daylight-PDT With MAL for AK and Photodamaged Skin

NCT02736760 | Completed Phase 4 DMC

• 1 other identifier: Daylight_01
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 4

Brief Summary

This study is a multicenter study investigating the clinical efficacy of repetitive daylight-PDT with MAL (Methylaminolevulinate) compared to cryosurgery in regard to prophylaxis and treatment of AKs (actinic keratoses) in the face. Patients will be randomly allocated to treatment groups. 5 PDT (photodynamic therapy) treatment sessions (visits 1-5) will be performed within 18 months. In the control group, cryosurgery will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5. In the PDT group the patients will apply a chemical sunscreen (SPF 50+) to the whole face and other light-exposed, unprotected areas of the skin. After at least 15 minutes a lesion preparation of AKs (removal of crusts) will be performed and MAL will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours. In the control group, cryosurgery will be performed using liquid nitrogen spray in each AK lesion; this will be done at visit 1 and, if necessary, also at visits 2-5. At visits 2-6, the efficacy of the treatment will be evaluated by the observer by documenting all existing and newly appearing AKs in the face.

Conditions

Actinic Keratoses; Photodamaged Skin

Outcome Measures

Primary Outcomes (1)

• The cumulative number of observed AKs at time points 2 to 6 (3 months after the first treatment to 24 months after the first treatment).

  Newly occured AK lesions are counted at visit 2, visit 3, visit 4, visit 5 and visit 6. The number of newly occured AK lesions during the study are added up, therefore we included the term "cumulative".

  24 months after the first treatment

Secondary Outcomes (7)

• Complete clearance of AKs on lesion basis

  This outcome measure is assessed three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment.

• Complete clearance of AKs on patient basis

  This outcome measure is assessed three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment.

• Photodamage parameters (fine lines, mottled pigmentation, tactile roughness, teleangiectasias, sallowness and global score for photoaging) will be evaluated on a 5-point scale according to Dover et al.

  This outcome measure is assessed at day 0 (= the first treatment), three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment.

• Visual pain score

  This outcome measure is assessed at day 0 (= the first treatment), three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment

• Adverse events

  This outcome measure is assessed at day 0 (= the first treatment), three months after the first and the second treatment and 6 months after the third, fourth and fifth treatment

Study Arms (2)

Daylight photodynamic therapy (PDT)

EXPERIMENTAL

One intervention in the daylight photodynamic therapy arm: Daylight photodynamic therapy using Methylaminolevulinate (MAL) will be performed five times within 18 months (visits 1-5). In the PDT group the patients will apply a chemical sunscreen (SPF 50+) to the whole face and other light-exposed, unprotected areas of the skin. After at least 15 minutes a lesion preparation of AKs (removal of crusts) will be performed and methylaminolevulinate (MAL) will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours.

Drug: Daylight photodynamic therapy using Methylaminolevulinate (MAL)

Cryosurgery

ACTIVE COMPARATOR

In the control group, cryosurgery will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5. In the control group, cryosurgery will be performed using liquid nitrogen spray in each AK lesion; this will be done at visit 1 and, if necessary, also at visits 2-5. At visits 2-6, the efficacy of the treatment will be evaluated by the observer by documenting all existing and newly appearing AKs in the face.

Procedure: Cryosurgery

Interventions

Daylight photodynamic therapy using Methylaminolevulinate (MAL) DRUG

In the Daylight photodynamic therapy arm the patients will apply a sunscreen to the whole face which is followed by lesion preparation of AKs. Following this, MAL will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours. 5 photodynamic therapy treatment sessions (visits 1-5) will be performed within 18 months.

Also known as: Daylight-PDT

Daylight photodynamic therapy (PDT)

Cryosurgery PROCEDURE

In the control group, cryosurgery as standard reference therapy will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5. Cryosurgery of AK lesions will be investigated as standard reference therapy. Single freeze-thaw cryosurgery is performed using an open spraying procedure with liquid nitrogen with nozzle size C. After formation of an ice-ball of the required size, freeze time starts. Freeze time should lie between 5 s and 10 s.

Cryosurgery

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent has been signed prior to or at Screening Visit
• Male and female patients with Fitzpatrick skin type I-IV
• Age \> 40 years
• Negative pregnancy test in women of childbearing age
• Women in child-bearing age using highly efficient contraceptive methods (\<1% failure rate per year)
• Clinical diagnosis of actinic keratosis (AK)
• A minimum of five non-hyperkeratotic, non-pigmented AK lesions in the face.
• Glogau Photodamage Classification Type II (moderate) - IV (severe)

You may not qualify if:

• Diagnosis of porphyria
• Hyperkeratotic or pigmented AK in the face
• Malignant skin tumors in the face or on the capillitium, requiring treatment
• Patients with clinically relevant suppression of the immune system (e.g. drug induced, infection) or organ transplant patients
• Pregnancy or lactation
• Planned aesthetic treatments in the face in the next 24 months (filler, peeling, botulinumtoxin, skin resurfacing)
• Known intolerance or allergy to MAL or to any other ingredient of Metvix® 160mg/g cream
• Known intolerance to Actinica® lotion
• Photosensitivity
• Suspected lack of compliance (e.g. due to dementia)
• Concomitant UV-phototherapy
• Skin diseases that might interfere with response evaluation of study treatment
• Skin sun sensitivity type V or VI according to Fitzpatrick
• PDT in the face during 6 months preceding study treatment
• Non-permitted medication:

Sponsors & Collaborators

• University Hospital Regensburg: lead

Study Sites (4)

University hospital Regensburg

Regensburg, Bavaria, 93053, Germany

Location

Hautzentrum Köln

Cologne, 50966, Germany

Location

University Hospital Düsseldorf.

Düsseldorf, 40225, Germany

Location

Klinikum Vest GmbH Knappschaftskrankenhaus

Recklinghausen, 45657, Germany

Location

Related Publications (1)

• Kohl E, Koller M, Zeman F, Szeimies RM, Philipp-Dormston WG, Prager W, Gerber PA, Karrer S. Daylight photodynamic therapy versus cryosurgery for the treatment and prophylaxis of actinic keratoses of the face - protocol of a multicenter, prospective, randomized, controlled, two-armed study. BMC Dermatol. 2017 Oct 25;17(1):12. doi: 10.1186/s12895-017-0064-7.

  PMID: 29070025 DERIVED

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 11, 2016
• First Posted: April 13, 2016
• Study Start: March 3, 2016
• Primary Completion: September 9, 2018
• Study Completion: September 9, 2018
• Last Updated: November 9, 2020

Record last verified: 2020-11

Locations

DE (4)