Background
Methods/design
Study design
Inclusion and exclusion criteria
Study treatment
Score | 0 | 1 | 2 | 3 | 4 |
---|---|---|---|---|---|
Global score for photoaging | facial skin smooth to the touch, no significant fine lines, uneven pigmentation, deep wrinkles, erythema, teleangiectasias, sebaceous gland hyperplasia on the cheeks, forehead, or in the perioral area | one area (cheeks, forehead, or perioral area) of significant roughness, deep wrinkles, erythema, teleangiectasias, sebaceous gland hyperplasia, dyspigmentation or fine lines | two areas of significant roughness, deep wrinkles, erythema, teleangiectasias, sebaceous gland hyperplasia, dyspigmentation or fine lines or one area of significant roughness, deep wrinkles, erythema, teleangiectasias, sebaceous gland hyperplasia, dyspigmentation and fine lines | three areas of significant roughness, deep wrinkles, erythema, teleangiectasias, sebaceous gland hyperplasia, dyspigmentation or fine lines or one area of significant roughness, deep wrinkles, erythema, teleangiectasias, sebaceous gland hyperplasia, dyspigmentation and fine lines | facial skin with photodamage higher than grade 3 |
Fine lines | none | very few, widely disseminated lines | some discreet lines | a moderate number of lines, in close proximity | many lines, in close proximity |
Mottled pigmentation | evenly pigmented skin | minor hypo-pigmentation or hyper-pigmentation | small areas of very light hypo-pigmentation or hyper-pigmentation or moderately sized areas of light hypo-pigmentation or hyper-pigmentation | moderate hypo-pigmentation or hyper-pigmentation or small areas of pronounced hypo- pigmentation or hyper-pigmentation | major hypo- pigmentation or hyper-pigmentation |
Skin color | pale pink | pale | yellowish, greyish | pale, slightly yellowish-greyish | pale, distinctly yellowish-greyish |
Tactile roughness | soft skin | soft, some rough areas | minor roughness | moderate roughness | major roughness |
Teleangiectasias | none | rare, widely disseminated | some discreet teleangiectasias | a moderate number of teleangiectasias, in close proximity | many teleangiectasias, in close proximity |
Deep wrinkles | none | superficial wrinkles in one area | superficial wrinkles in more than one area or moderately deep wrinkles in one area | moderately deep wrinkles in more than one area or deep wrinkles in one area | deep wrinkles in more than one area |
Facial erythema | none | small areas with slight erythema | small areas with moderate erythema or moderately sized areas with slight erythema | moderately sized areas with erythema | large areas with erythema |
Sebaceous gland hyperplasia | none | some in one area | some in several areas or several in one area | a moderate number in several areas or many in close proximity in one area | many in close proximity in more than one area |
Time | - 4 weeks – 0 d+ | d 0+ | 3 months after V1#
| 3 months after V2#
| 6 months after V3#
| 6 months after V4#
| 6 months after V5#
|
---|---|---|---|---|---|---|---|
Visit | Screening | 1 | 2 | 3 | 4 | 5 | 6 |
Study treatment Test-group: Fullface-Daylight-PDT | 1.PDT | 2.PDT | 3.PDT | 4.PDT | 5.PDT | ||
Study treatment Control-group: cryosurgery | Cryo | Cryo° | Cryo° | Cryo° | Cryo° | ||
Documentation of AK lesions in the face | X | X | X | X | X | X | |
Randomization | X | ||||||
Obtaining Informed Consent | X | ||||||
Check of Inclusion/ Exclusion Criteria | X | X | X | X | X | X | X |
Medical history | X | ||||||
Photodocumentation | X | X | X | X | X | X | |
Assessment of photoaging parameters | X | X | X | X | X | X | |
Documentation of newly occurred malignant skin tumors in the face | X | X | X | X | X | X | |
Documentation of AEs and SAEs | X | X | X | X | X | X | |
Pain score (VAS) during treatment | X | X | X | X | X | ||
Skin-related quality of Life (DLQI) | X | X | |||||
Patient satisfaction with cosmetic results | X | X | X | X | X | ||
Investigator satisfaction with cosmetic results | X | X | X | X | X | ||
Local skin reactions | X | X | X | X | X | ||
Pregnancy test | X | X | X | X | X | X |