JRCT ID: jRCT1070250117
Registered date:19/12/2025
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
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | N/A, healthy people. |
| Date of first enrollment | 01/01/2026 |
| Target sample size | 5 |
| Countries of recruitment | |
| Study type | Other |
| 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. |
Outcome(s)
| Primary Outcome | 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 | 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 |
Key inclusion & exclusion criteria
| Age minimum | >= 20age old |
|---|---|
| Age maximum | <= 60age old |
| Gender | Both |
| Include 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. |
| Exclude 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. |
Related Information
| Primary Sponsor | Utako Kimura |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Japan Bio Products Co., Ltd. |
| Secondary ID(s) |
Contact
| Public contact | |
| Name | Kimura Utako |
| Address | Daikanyama Parks 2F, 4-21-2, Ebisu-nishi, Shibuya-ku, Tokyo Tokyo Japan 150-0021 |
| Telephone | +81-120-022-118 |
| utako@juntendo.ac.jp | |
| Affiliation | Dr.Spa Clinic |
| Scientific contact | |
| Name | Kimura Utako |
| Address | Daikanyama Parks 2F, 4-21-2, Ebisu-nishi, Shibuya-ku, Tokyo Tokyo Japan 150-0021 |
| Telephone | +81-120-022-118 |
| utako@juntendo.ac.jp | |
| Affiliation | Dr.Spa Clinic |