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

Primary Purpose

Athletic Injuries, Eczematous Skin Diseases, Skin Avulsion

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Hydrating Cream
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Athletic Injuries focused on measuring Hydrating cream, Eczematous Skin Diseases, Skin Avulsion, Athletic Injuries

Eligibility Criteria

13 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Hydrating cream group

    Arm Description

    The subjects will be instructed to apply the Hydrating Cream to the more severely affected side as the experimental group (e.g., the more severely injured left or right hand of tug-of-war athletes). At the same time, the other limb will be regarded as the control group. The study lasted for two weeks, and after two weeks, the experimental and control groups were switched, with the entire observation process lasting four weeks.

    Outcomes

    Primary Outcome Measures

    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.
    Change in skin lesion area
    The area of skin damage was estimated using the palmar method and recorded with photographs (excluding the face)

    Secondary Outcome Measures

    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.
    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

    Full Information

    First Posted
    May 2, 2023
    Last Updated
    May 14, 2023
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05861713
    Brief Title
    Using Hydrating Cream to Improve Repeated Hand Skin Injury Among Tug-of-war Players
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 15, 2023 (Anticipated)
    Primary Completion Date
    December 15, 2023 (Anticipated)
    Study Completion Date
    March 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Athletic Injuries, Eczematous Skin Diseases, Skin Avulsion
    Keywords
    Hydrating cream, Eczematous Skin Diseases, Skin Avulsion, Athletic Injuries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Single Group Assignment
    Model Description
    Evaluation of the efficacy of Hydrating Cream on Tug-of-war player with repeated hands injury by using a single arm, open-label, split-hand crossover design clinical study
    Masking
    None (Open Label)
    Masking Description
    Since the Hydrating Cream is applied to the subjects' hands and therefore masking is difficult to be done, the investigators adopt open-label design for this study
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Hydrating cream group
    Arm Type
    Experimental
    Arm Description
    The subjects will be instructed to apply the Hydrating Cream to the more severely affected side as the experimental group (e.g., the more severely injured left or right hand of tug-of-war athletes). At the same time, the other limb will be regarded as the control group. The study lasted for two weeks, and after two weeks, the experimental and control groups were switched, with the entire observation process lasting four weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Hydrating Cream
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in skin symptoms
    Description
    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.
    Time Frame
    day 0 (before use), day 14 (exchange date), and day 28 (end of the trial)
    Title
    Change in skin lesion area
    Description
    The area of skin damage was estimated using the palmar method and recorded with photographs (excluding the face)
    Time Frame
    day 0 (before use), day 14 (exchange date), and day 28 (end of the trial)
    Secondary Outcome Measure Information:
    Title
    Change in skin moisturization
    Description
    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.
    Time Frame
    day 0 (before use), day 14 (exchange date), and day 28 (end of the trial)
    Title
    Change in quality of life
    Description
    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
    Time Frame
    day 0 (before use), day 14 (exchange date), and day 28 (end of the trial)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    13 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hsing-Yu Chen, MD
    Phone
    +886-975366119
    Email
    b8705016@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The raw data sharing is only available on adequate request and could only be released if approved by the Institutional Review Board of the Chang Gung Medical Foundation.
    Citations:
    PubMed Identifier
    36255396
    Citation
    Hsieh CY, Tsai TF. Friction-Aggravated Skin Disorders-A Review of Mechanism and Related Diseases. Dermatitis. 2023 Jul-Aug;34(4):287-296. doi: 10.1097/DER.0000000000000961. Epub 2023 Jan 2.
    Results Reference
    background
    PubMed Identifier
    16403110
    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.
    Results Reference
    background
    PubMed Identifier
    32573826
    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.
    Results Reference
    result

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

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