Using Hydrating Cream to Improve Repeated Hand Skin Injury Among Tug-of-war Players

Athletic Injuries Clinical Trial

Official title:

Using Hydrating Cream to Improve Repeated Hand Skin Injury Among Tug-of-war Players: a Single Arm, Open-label, Split-hand Crossover Design Clinical Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05861713
• Other study ID #: 202300283A3
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: May 15, 2023
• Est. completion date: March 15, 2024

Study information

• Verified date: April 2023
• Source: Chang Gung Memorial Hospital
• Contact: Hsing-Yu Chen, MD
• Phone: +886-975366119
• Email: b8705016[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Athletes commonly face skin injuries during training and competition, which can negatively impact their performance and physical health. Injuries such as abrasions, cuts, burns, and sunburns can limit muscle contractions and range of motion, cause discomfort, and lead to bacterial infections. In addition, skin damage can lead to long-term skin problems such as skin aging and cancer, affecting athletes' overall health and performance. Protecting the skin is crucial for athletes to maintain optimal performance and physical health. The use of steroids is limited for athletes due to their status as banned substances. Topical steroids may also cause negative side effects, making it necessary to find alternative skin care options for athletes such as tug-of-war athletes. This study aims to evaluate the effectiveness of a topical hydrating cream for skin care in this population. The study involved using a moisturizing cream on the more severely affected side of one hand while the other hand acted as a comparative control group. After two weeks, the sides were switched, and the study continued for four weeks in total.

Description:

Skin damage is a common issue for athletes. Whether during training or competition, athletes often face various skin injuries such as abrasions, cuts, bruises, burns, sunburns, etc. These injuries can have negative impacts on their body and performance, making the importance of protecting the skin self-evident. Firstly, skin damage may affect an athlete's sports performance. In an athlete's competition, any injury may affect their performance and result. Abrasions and bruises may limit muscle contractions, thereby affecting their ability and speed. Cuts and burns may also restrict their range of motion, especially in sports that require high flexibility, such as dance and gymnastics. Even minor injuries, such as blisters and abrasions, may cause discomfort and reduce their performance. Secondly, skin damage may also have negative impacts on an athlete's physical health. Abrasions and cuts may lead to bacterial infections, especially when using public facilities during competitions, such as showers and changing rooms. These infections may cause symptoms such as redness, fever, inflammation, and pus, and may require medication for treatment in severe cases. Sunburns and burns may lead to skin aging, skin cancer, and other skin problems, which may affect an athlete's long-term health and performance. Athletes have limited treatment options, as steroids are one of the important banned substances in sports. Even topical steroid creams may enter the bloodstream after long-term and widespread use, which can be detected in urine tests. Therefore, athletes should avoid using them as much as possible. In addition, topical steroids can cause side effects such as pigment deposition, skin thinning, bleeding, and even infection. Therefore, finding suitable topical medications for skin care in tug-of-war athletes is still necessary to avoid skin complications and potential impacts on performance. The purpose of this study is to clinically verify the effectiveness of the topical cream "Hydrating cream" for skin care in tug-of-war athletes and to evaluate its applicability and feasibility.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: March 15, 2024
• Est. primary completion date: December 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 75 Years

Eligibility

Inclusion Criteria:

• Dry and cracked skin lesions

• Not using any topical agents or emollients,

Exclusion Criteria:

• Malignancies or autoimmune disease-related skin lesions, such as psoriasis, systemic lupus erythematosus, dermatomyositis, etc.

• Under treatment of any kind or antibiotics

• Use oral, parental, or local corticosteroids in the recent one month

• Severe psychiatric illnesses, such as mania, major depression, bipolar or schizophrenia, etc.

• Known history of allergic to wool-related products.

Related Conditions & MeSH terms

• Athletic Injuries
• Degloving Injuries
• Skin Diseases
• Skin Diseases, Eczematous
• Wounds and Injuries

Intervention

Drug:
• Hydrating Cream
The experimental group will apply the Hydrating Cream to the affected skin area at least twice daily with a cotton swab, while the other limb was the control group.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

References & Publications (3)

Hsieh CY, Tsai TF. Friction-Aggravated Skin Disorders-A Review of Mechanism and Related Diseases. Dermatitis. 2022 Oct 17. doi: 10.1097/DER.0000000000000961. Online ahead of print. — View Citation

Logger JGM, Driessen RJB, de Jong EMGJ, van Erp PEJ. Value of GPSkin for the measurement of skin barrier impairment and for monitoring of rosacea treatment in daily practice. Skin Res Technol. 2021 Jan;27(1):15-23. doi: 10.1111/srt.12900. Epub 2020 Jun 23 — View Citation

McMullen E, Gawkrodger DJ. Physical friction is under-recognized as an irritant that can cause or contribute to contact dermatitis. Br J Dermatol. 2006 Jan;154(1):154-6. doi: 10.1111/j.1365-2133.2005.06957.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in skin symptoms	The change in skin symptoms after using the Hydrating Cream will be evaluated using a visual analog scale, which ranges from 0 to 100, and a higher score indicates more severe skin symptoms.	day 0 (before use), day 14 (exchange date), and day 28 (end of the trial)
Primary	Change in skin lesion area	The area of skin damage was estimated using the palmar method and recorded with photographs (excluding the face)	day 0 (before use), day 14 (exchange date), and day 28 (end of the trial)
Secondary	Change in skin moisturization	Quantification of skin moisture. This will be assessed by GPskin Barrier Pro, which detects trans-epidermal water loss (TEWL) and stratum corneum hydration (SCH), both important indicators of skin moisturization.	day 0 (before use), day 14 (exchange date), and day 28 (end of the trial)
Secondary	Change in quality of life	Assessed using the generic EQ-5D-5L scale for overall quality of life and the Dermatology Life Quality Index (DLQI) for skin-related quality of life simultaneously	day 0 (before use), day 14 (exchange date), and day 28 (end of the trial)