Tokyo, March 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061085) titled 'Study on the Effectiveness of a Liquid Bandage for Minor Skin Abrasions' on March 27.

Study Type: Interventional

Study Design: Basic Design - n-of-1 Randomization - Randomized Blinding - Open -no one is blinded Control - Self control

Primary Sponsor: Institute - KOBAYASHI Pharmaceutical Co., Ltd.

Condition: Condition - Superficial abrasion wounds Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the real-world effectiveness of liquid bandage compared to adhesive bandage in promoting wound healing among consumers with superficial wounds. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - In this randomized, self-controlled trial, participants with at least two superficial abrasion wounds (1-3 cm) on opposite sides of the body receive two treatments. One wound is treated with a pyroxylin-based liquid bandage, and the contralateral wound is treated with a conventional adhesive bandage with a wound pad as a control. The healing process is evaluated and compared between the two sites over a 30-day period.

Eligibility: Age-lower limit - 21 years-old = Gender - Male and Female Key inclusion criteria - 1. Healthy males and females aged between 21 and 64 years old. 2. Have 2 or more abrasions that occurred within one day (equivalent to Stage I of StatPearls Wound Assessment), with at least one on each side of the upper or lower extremities. 3. Have a fresh superficial wound with a wound surface area of 1-3 cm (inclusive) in diameter (corresponding to an area of 0.79-7.07cm2). Wounds need to have a moist surface, with no visible bleeding or mild visible bleeding, and not yet have formed a crust or scab. 4. Recommended to use liquid bandage or adhesive bandage as per routine clinical practice. Key exclusion criteria - 1. Individuals suffering from or currently being treated for serious diseases such as diabetes, cancer, kidney disease, liver disease, thyroid disease, adrenal disease, or metabolic diseases that may significantly affect the healing process, or those with a history of such conditions. 2. Individuals suffering from or currently being treated for chronic bedsores, immune disorders, infections that may affect the healing process, or those with a history of such conditions. 3. Individuals who routinely consume collagen peptides. 4. Individuals with Fitzpatrick Classification skin types V - VI (due to higher susceptibility to keloids and hypertrophic scars). 5. Individuals with acne, sunburn, eczema, scars, excessive hair, acute skin infections, hyperpigmentation, hypopigmentation, or tattoos near the target wound. 6. Pregnant or breastfeeding individuals, those who may be pregnant, or those planning to become pregnant. 7. Individuals currently participating in, or who have participated in, clinical trials related to wound care or wound healing within the past 3 months. 8. Individual deemed unsuitable for this study by the Principal Investigator. Target Size - 8

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 09 Month 25 Day Date of IRB - 2026 Year 03 Month 11 Day Anticipated trial start date - 2026 Year 04 Month 01 Day Last follow-up date - 2026 Year 08 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069897

Disclaimer: Curated by HT Syndication.