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

Phase 3

• Conditions: Nail Abnormalities
• Interventions: Drug: Nail gel

• Registration Number: NCT02582762
• Lead Sponsor: Mahidol University

Brief Summary

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

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-09
• Status Verified: 2015-10
• Study First Submitted: 2015-10-18
• Study First Submitted QC: 2015-10-19
• Last Update Submitted: 2015-10-19
• Study First Posted: 2015-10-21
• Last Update Posted: 2015-10-21
• Primary Completion: 2016-03
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Age 18 years old or above
2. Being diagnosed nail surface abnormalities stably more than 3 months

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Exclusion Criteria

1. Having severe or uncontrolled concomitant diseases
2. Having nail infection
3. History of manicure within the last 1 month
4. Use of Biotin or other nail modifying drugs within the previous 3 months
5. Pregnancy or lactation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nail gel	Nail gel	apply nail gel twice daily

Primary Outcome Measures

Name	Time	Method
Improvement overall nail surface abnormalities	2 weeks and 8 weeks	Number of nails of each participant with change/improvement nail surface using clinical assessment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Siriraj Hospital, Mahidol University; 🇹🇭 Bangkok, Bangkoknoi, Thailand