臨床研究等提出・公開システム

Date of registration	Dec. 19, 2025
Last modified on	Dec. 19, 2025
Trial ID	jRCT1070250117

Scientific Title	Evaluation of the Efficacy, Safety, and Patient Self-Assessment in Reducing Downtime by Use of Membrane Formation Collagen Hydrogel Following Ablative CO2 Fractional Laser Resurfacing
Public Title	Evaluation of the Efficacy, Safety, and Patient Self-Assessment in Reducing Downtime by Use of Membrane Formation Collagen Hydrogel Following Ablative CO2 Fractional Laser Resurfacing

Contact for Scientific Queries	Name	Utako Kimura
	Affiliation	Dr.Spa Clinic
	Address	Daikanyama Parks 2F, 4-21-2, Ebisu-nishi, Shibuya-ku, Tokyo
	Telephone	+81-120-022-118
	E-mail	utako@juntendo.ac.jp
Contact for Public Queries	Name	Utako Kimura
	Affiliation	Dr.Spa Clinic
	Address	Daikanyama Parks 2F, 4-21-2, Ebisu-nishi, Shibuya-ku, Tokyo
	Telephone	+81-120-022-118
	E-mail	utako@juntendo.ac.jp

Recruitment status	Pending

Anticipated date of first enrollment		Jan. 01, 2026
Target sample size		5
Study Type		Other
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	single assignment
	purpose	other
Key inclusion & exclusion criteria	Inclusion Criteria	Healthy Asian people aged 20~60. Skin type: 3-4 Someone is available in this study's schedule. Someone who is less revealed in sunlight during the observational period. Someone who can accept researchers' orders.
	Exclusion Criteria	Someone who has received the facial treatment for aesthetic purposes within 90 days before this study. Chemical Sensitivity, especially alcoholic sensitivity. Someone subject to the contraindication of Ablative CO2 Fractional Laser Resurfacing. Someone whom the researcher considers not appropriate for this study.
	Age Minimum	20age old over
	Age Maximum	60age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		N/A, healthy people.
Intervention(s)		Same subject, the treatment area is on their face. Intervention-side: The left side of the treatment area is subjected to membrane formation collagen hydrogel after treatment. Control side: The right side of the treatment area is subjected to White Petrolatum.
Health Condition(s) Keyword		N/A
Primary Outcome(s)		1. Statistical analysis of red images acquired by an imaging device 2. Statistical significance of differences between left and right sides in the mean stratum corneum moisture content and TEWL values for all subjects post-treatment.
Secondary Outcome(s)		1. Presence of adverse events (AE) items 7 days and 14 days after treatment by the physician. AE items: Erythema, Edema, Pinpoint Bleeding, Oozing, Crusting 2 Subject self-assessment in the use of both products, questionnaire survey of subjects from 1 to 3 days after treatment

Primary Sponsor	none

Secondary Sponsor

Source of Monetary Support	Japan Bio Products Co., Ltd.
Secondary Sponsor	Not applicable

Name of Certified Review Board	Nogcli dermatology Clinic cetrified CRB
Address	964-1 Kamishima, Kashima-machi, Kamimashiki-gun, Kumamoto, Kumamoto
Telephone	+81-96-237-4112
E-Mail	derma@nogcli.jp
Approval Status	Approval
Date of approval	Nov. 17, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none