Pilot Study of Efficacy of Nail Gel in Finger Nail Surface Abnormality

Study Overview
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Brief Summary
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Nail surface abnormalities is any conditions that affect the nail matrix or nail bed which cause nail plates grow defectively. Common nail surface abnormalities are pitting nails, longitudinal ridging, and transverse ridging/Beau's line. Aging nails usually have nail surface abnormalities as well. Nail gels are artificial nails used widely for aesthetic purposes. Although, their cosmetic use is increasing with day by day, their usefulness in conditions such as nail biting, brittle nails, and ingrown toe nails has been reported. Moreover, a previous study reported the benefits of nail gels in terms of improving nail surface abnormalities like pitting nails, trachyonychia, and onychoschizia. This study was conducted to evaluate the efficacy of nail gel containing Glycerin which has humectant effect and Artemisia Abrotanum extract which has anti-fungal/bacterial activities in finger nail surface abnormalities.

Detailed Description
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Evaluation of nail surface abnormality can be done by using Visiometer® (bioengineering measurement) and dermoscope. Both techniques are non-invasive. Artemisia Abrotanum extract has been used as ingredient in cosmetic products and its safety has been declared. Undesirable events from external using products containing this substance have never been reported yet. Nail gel product in this study has been approved as a cosmetic product by Food and Drug Administration of Thailand (Thai FDA).

Official Title
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Pilot Study of Efficacy of Nail Gel Containing Artemisia Abrotanum Extract and Glycerin in Finger Nail Surface Abnormality

Conditions
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Nail Abnormalities

Intervention / Treatment
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* Drug: Nail gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years old or above Being diagnosed nail surface abnormalities stably more than 3 months Exclusion Criteria: Having severe or uncontrolled concomitant diseases Having nail infection History of manicure within the last 1 month Use of Biotin or other nail modifying drugs within the previous 3 months Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nail gel<br>apply nail gel twice daily | Drug: Nail gel<br>* apply nail gel on affected nails twice daily for 2 months<br>* Other names: Locycare;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement overall nail surface abnormalities | Number of nails of each participant with change/improvement nail surface using clinical assessment | 2 weeks and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement roughness of nail surface abnormalities | Number of nails of each participant with change/improvement nail surface using bioengineering measurement | 2 weeks, and 8 weeks | 
| Increase nail hydration | Number of nails of each participant with the increase of nail hydration using bioengineering measurement | 2 weeks, and 8 weeks | 
| Patients's satisfaction | good patients's satisfaction outcome by self-questionnaire | 2 weeks and 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nail gel, Nail surface abnormality, Efficacy