臨床研究等提出・公開システム

Japanese

Date of registration	Nov. 05, 2019
Last modified on	May. 01, 2022
Trial ID	jRCTs032190128

Scientific Title	A comparative study of erythema reaction using ultraviolet therapy devices with different irradiance
Public Title	A comparison of erythema reaction in two ultraviolet irradiation devices

Completion date	May. 14, 2020
Result actual enrolment	15
Baseline Characteristics	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
Participant flow	15 enrolled cases, 15 safety analysis set, 15 full analysis set (FAS), 15 per protocol Set (PPS) conforming to the study protocol
Adverse events	No adverse events or serious adverse events occurred except for 2 minor reversible pigmentation.
Outcome measures	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
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.
Date of posting of results summaries	May. 01, 2022
Date of the first journal publication of results	May. 01, 2022
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	No plan
URL link to protocol file(s) with version and date	https://jrct.niph.go.jp/latest-detail/jRCTs032190128

Contact for Scientific Queries	Name	Togawa Yaei
	Affiliation	Chiba university
	Address	1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
	Telephone	+81-43-222-7171
	E-mail	togawa-yk@faculty.chiba-u.jp
Contact for Public Queries	Name	Togawa Yaei
	Affiliation	Chiba university
	Address	1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba, Japan
	Telephone	+81-43-222-7171
	E-mail	togawa-yk@faculty.chiba-u.jp

Recruitment status	Complete

Anticipated date of first enrollment		Nov. 05, 2019
Actual date of first enrollment		Nov. 30, 2019
Target sample size		15
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	dose comparison control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	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
	Age Minimum	20age old over
	Age Maximum	65age old not
	Gender	Both
Health Condition(s) or Problem(s) Studied		Health Condition(s)
Intervention(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
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Difference in erythema value
Secondary Outcome(s)		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

Primary Sponsor

Source of Monetary Support / Secondary Sponsor	JMEC Corporation
Secondary Sponsor	Not applicable

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Chiba University Certified Clinical Research Review Board
Address	1-8-1, Inohana, Chuo-ku, Chiba-City, Chiba
Telephone	+81-43-226-2616
E-Mail	prc-jim@chiba-u.jp
Approval Status	Approval
Date of approval	July. 16, 2019

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	May. 01, 2022	(this page)	Changes
4	July. 05, 2021	Detail	Changes
3	June. 26, 2020	Detail	Changes
2	April. 30, 2020	Detail	Changes
1	Nov. 05, 2019	Detail

List of change history