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Athletic InjuriesPhase 2/3NCT05861713

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

A Phase 2/3 study testing Hydrating Cream in people with Athletic Injuries and Eczematous Skin Diseases, run by Chang Gung Memorial Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 13 to 75 years
What is being tested?
Hydrating Cream
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
15 May 2023to 15 Mar 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Dry and cracked skin lesions
  • Not using any topical agents or emollients,

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet.

Hsing-Yu Chen, MD contact

+886-975366119

b8705016@gmail.com

About this study

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

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.

Read the 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.

Being tested
Hydrating Cream
Keywords
Hydrating cream, Eczematous Skin Diseases, Skin Avulsion, Athletic Injuries
Medical subject headings
Athletic Injuries, Skin Diseases, Eczematous, Degloving Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydrating CreamDrug

    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.

Study groups in NCT05861713
Study groupRoleWhat they receive
Hydrating cream groupExperimentalThe 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.
Receives: Drug: Hydrating Cream

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: day 0 (before use), day 14 (exchange date), and day 28 (end of the trial)

  2. Change in skin lesion area

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

    Measured: day 0 (before use), day 14 (exchange date), and day 28 (end of the trial)

Secondary outcomes (2)

  1. 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.

    Measured: day 0 (before use), day 14 (exchange date), and day 28 (end of the trial)

  2. 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

    Measured: day 0 (before use), day 14 (exchange date), and day 28 (end of the trial)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2023
  2. Study start15 May 2023 (estimated)
  3. Primary completion15 Dec 2023 (estimated)
  4. Study completion15 Mar 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05861713
Sponsor's protocol ID
202300283A3
Status last verified
Apr 2023
First submitted
2 May 2023
Last updated
17 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 36255396

  • 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.

    PubMed 16403110

  • 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.

    PubMed 32573826

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Hydrating Cream in people with Athletic Injuries and Eczematous Skin Diseases, run by Chang Gung Memorial Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hsing-Yu Chen, MD (+886-975366119, b8705016@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in skin symptoms (time frame: day 0 (before use), day 14 (exchange date), and day 28 (end of the trial)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05861713, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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