ClinicalTrials.gg
Status unknownNCT05861713Updated May 17, 2023

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

A Phase 2/3 interventional study of Hydrating Cream in Athletic Injuries, Eczematous Skin Diseases and Skin Avulsion, sponsored by Chang Gung Memorial Hospital. Status unknown. Open to participants aged 13 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-17.

Sponsored by Chang Gung Memorial Hospital · Phase 2/3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
13 Years to 75 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Athletic Injuries
  • Eczematous Skin Diseases
  • Skin Avulsion

Keywords

  • Hydrating cream
  • Eczematous Skin Diseases
  • Skin Avulsion
  • Athletic Injuries
03

In context

Athletic Injuries

258 studies on the registry are indexed under Athletic Injuries; 45 are open to participants now.

This study's planned enrollment of 30 is below the median of 44 across 164 interventional studies indexed under Athletic Injuries.

Browse Athletic Injuries studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,096 studies on the registry; 239 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • or disease-related skin lesions, such as psoriasis, systemic lupus erythematosus, dermatomyositis, etc.
  • Under treatment of any kind or antibiotics
  • Use oral, parental, or local 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Hydrating cream group

    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.

    Drug: Hydrating Cream

Interventions

  • DrugHydrating 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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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)

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

Secondary outcomes

  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.

    Time frame: 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

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

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: 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.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2023; primary completion for Dec 2023, 7 months later.

How these figures are worked out, and which studies are left out of them.

Registered
May 2, 2023
First posted
May 17, 2023
StartEst.
May 15, 2023
Primary completionEst.
Dec 15, 2023
CompletionEst.
Mar 15, 2024
Last update
May 17, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 17, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05861713
Responsible party
Sponsor
First posted
May 17, 2023
Start date
May 15, 2023 (estimated)
Primary completion
Dec 15, 2023 (estimated)
Completion
Mar 15, 2024 (estimated)
Last update
May 17, 2023

Study contacts

Hsing-Yu Chen, MD
Contact
b8705016@gmail.com
+886-975366119

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion