A comparison of erythema reaction in two ultraviolet irradiation devices

Phase 2

• Conditions: Health Condition(s)

• Registration Number: JPRN-jRCTs032190128
• Lead Sponsor: Togawa Yaei

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-05
• Study Completion: 2020-05-14
• Results First Posted: 2022-05-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in erythema value

Secondary Outcome Measures

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