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A comparative study of erythema reaction using ultraviolet therapy devices with different irradiance

A comparison of erythema reaction in two ultraviolet irradiation devices

15

Age 46.3 plus/minus10.2 (mean plus/minus SD), 8 females, 7 males, 8 with medical history/complications, 11 with medications in use, 12 with Fitzpatrick 2, 3 with 3

15 enrolled cases, 15 safety analysis set, 15 full analysis set (FAS), 15 per protocol Set (PPS) conforming to the study protocol

No adverse events or serious adverse events occurred except for 2 minor reversible pigmentation.

Primary endpoint Difference in erythema value (mexameter) There is a significant difference between 100 mJ/cm2 and 200 mJ/cm2 (p<0.05) Secondary evaluation item 1) Difference in erythema value (spectrophotometer CM-700d) No significant difference 2) Difference in erythema value in dermoscopy image There is a significant difference between 80 mJ/cm2 and 200 mJ/cm2 (p<0.05) 3) Number of micropapules in dermoscopy images Not observed 4) Number of vesicles in dermoscopy image Not observed 5) Judgment of average MED of each irradiance 50mW/cm2: 129.3plus/minus26.0 mJ/cm2 (average plus/minus SD) 150mW/cm2: 96.0plus/minus3.5 mJ/cm2 (average plus/minus SD) 6) Judgment of postoperative pigmentation (PIH) in dermoscopy images Day2 (24 hours later) None: 3 cases, suspicious: 12 cases Day169 None: 3 cases, suspicious: 4 cases, mild 8 cases

Significant differences were observed in the difference in erythema value (mesameter) of the primary endpoint and the difference in erythema value in the dermoscopy image of the secondary endpoint. No adverse events were observed, except for two reversible minor pigmentations.

May. 01, 2022

May. 01, 2022

No

No plan

https://jrct.niph.go.jp/latest-detail/jRCTs032190128

Togawa Yaei

Chiba university

1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan

togawa-yk@faculty.chiba-u.jp

Togawa Yaei

Chiba university

1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan

+81-43-222-7171

togawa-yk@faculty.chiba-u.jp

Complete

Nov. 05, 2019

Interventional

non-randomized controlled trial

open(masking not used)

dose comparison control

parallel assignment

treatment purpose

Target patients who meet all the following conditions.
1) Over 20 years old and under 65 years old
2) Those who can agree with the document regarding participation in this examination

1) photosensitivity
2) keloid diathesis
3) pregnant or having possibility of pregnancy
4) breast-feeding
5) any skin disorder in upper abdominal skin
6) any tattoo or pigmentation in upper abdominal skin
7) having history of sunburn within 2 months
8) having any medicines causing photosensitivity
9) inappropriate cases

Both

Health Condition(s)

Irradiate at 80, 100, 120, 140, 160, 180, and 200 mJ/cm2, respectively, using ultraviolet therapy equipment at 50 mW/cm2 and 150 mW/cm2

Difference in erythema value

1) The difference of erythema (spectrocolorimeter CM-700d)
2) Difference in erythema in dermoscopy images
3) Micropapules in dermoscopy images
4) Observation of small vesicles in dermoscopy images (number)
5) Determination of average MED of each irradiance
6) Determination of post-operative pigmentation (PIH) in dermoscopy images

+81-43-226-2616

none