Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Facies

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Dermatologic Agents

All Drugs and Chemicals

Sunscreening Agents

Methyl 5-aminolevulinate

Aminolevulinic Acid

Photosensitizing Agents

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.

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.

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.

Daylight photodynamic therapy using Methylaminolevulinate (MAL)

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

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.

This study is a multicenter study investigating the clinical efficacy of repetitive daylight-PDT with MAL compared to cryosurgery in regard to prophylaxis and treatment of AKs in the face. Patients will be randomly allocated to treatment groups. 5 PDT 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.

Before application of the photosensitizer, an organic sunscreen (Actinica® lotion, LSF 50+) without mineral filters will be applied In the entire face.

After an absorption time of approximately 15 minutes and before applying MAL (Metvix®), the surface of the AK lesions will be prepared gently with a curette or a scalpel to remove scales and crusts and roughen the surface of the AK-lesions. This is to facilitate penetration of the cream and light to the AK lesions.

After lesion preparation, MAL (Metvix®) will be uniformly applied on the whole face in a thin layer.

Within 30 min after MAL application the patients go outside and expose themselves for 2 hours to daylight. Daylight-PDT can be performed from March until October, during non-rainy weather with an outdoor temperature of at least 10° Celsius. Daylight exposure must start at least 3 hours before sunset.

At the end of the exposure, residual photosensitizer is washed off and the patients spend the rest of the day indoors.

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.

Daylight-PDT With MAL for AK and Photodamaged Skin

Prospective, Randomized, Controlled, Multicenter, Two-armed, Study Comparing Daylight Photodynamic Therapy Using MAL With Cryosurgery for the Treatment and Prophylaxis of Actinic Keratoses in Photodamaged Skin of the Face

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".

completely cleared AK lesions

The first treatment ist performed at day 0 The second treatment is performed 3 months after the first treatment. The third treatment is performed 3 months after the second treatment. The fourth treatment is performed 6 months after the third treatment. The fifth treatment is performed 6 months after the fourth treatment.

completely cleared AK lesions on patient basis

The first treatment ist performed at day 0 The second treatment is performed 3 months after the first treatment. The third treatment is performed 3 months after the second treatment. The fourth treatment is performed 6 months after the third treatment. The fifth treatment is performed 6 months after the fourth treatment.

Photodamage parameters will be evaluated on a 5-point scale according to Dover et al. at all visits during the study

The first treatment ist performed at day 0 (visit 1) The second treatment is performed 3 months after the first treatment (visit 2) The third treatment is performed 3 months after the second treatment (visit 3) The fourth treatment is performed 6 months after the third treatment (visit 4) The fifth treatment is performed 6 months after the fourth treatment (visit 5) The last visit is performed 6 months after the fifth treatment (visit 6)

For evaluation of tolerability of daylight-PDT and cryosurgery, a pain score (VAS) will be assessed and documented.

The first treatment ist performed at day 0 (visit 1) The second treatment is performed 3 months after the first treatment (visit 2) The third treatment is performed 3 months after the second treatment (visit 3) The fourth treatment is performed 6 months after the third treatment (visit 4) The fifth treatment is performed 6 months after the fourth treatment (visit 5) The last visit is performed 6 months after the fifth treatment (visit 6)

All adverse events and serious adverse events will be adequately documented.

The first treatment ist performed at day 0 (visit 1) The second treatment is performed 3 months after the first treatment (visit 2) The third treatment is performed 3 months after the second treatment (visit 3) The fourth treatment is performed 6 months after the third treatment (visit 4) The fifth treatment is performed 6 months after the fourth treatment (visit 5) The last visit is performed 6 months after the fifth treatment (visit 6)

For evaluation of satisfaction with cosmetic results, patients and investigators fill in a standardized rating scale

The first treatment ist performed at day 0 (visit 1) The second treatment is performed 3 months after the first treatment (visit 2) The third treatment is performed 3 months after the second treatment (visit 3) The fourth treatment is performed 6 months after the third treatment (visit 4) The fifth treatment is performed 6 months after the fourth treatment (visit 5) The last visit is performed 6 months after the fifth treatment (visit 6)

For evaluation of skin-related quality of life, study participants fill in the Dermatology Life Quality Index, a 10-item questionnaire for routine clinical use. Patients are asked about the impact of their AK and photodamaged skin and its treatment on their lives. Patients' quality of life is expressed in a single score ranging from 0 (no impact) to 30 (severe impact).

Spots Global Cancer Trial Database for photodamaged skin