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

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ClinicalTrials.gov Identifier: NCT02582762
Recruitment Status : Unknown
Verified October 2015 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : October 21, 2015
Last Update Posted : October 21, 2015
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Study Description
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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.


Condition or disease Intervention/treatment Phase
Nail Abnormalities Drug: Nail gel Phase 3

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).


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Efficacy of Nail Gel Containing Artemisia Abrotanum Extract and Glycerin in Finger Nail Surface Abnormality
Study Start Date : September 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : June 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: Nail gel
apply nail gel twice daily
 Drug: Nail gel
apply nail gel on affected nails twice daily for 2 months
Other Name: Locycare


Outcome Measures
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Primary Outcome Measures :
  1. Improvement overall nail surface abnormalities [ Time Frame: 2 weeks and 8 weeks ]
    Number of nails of each participant with change/improvement nail surface using clinical assessment


Secondary Outcome Measures :
  1. Improvement roughness of nail surface abnormalities [ Time Frame: 2 weeks, and 8 weeks ]
    Number of nails of each participant with change/improvement nail surface using bioengineering measurement

  2. Increase nail hydration [ Time Frame: 2 weeks, and 8 weeks ]
    Number of nails of each participant with the increase of nail hydration using bioengineering measurement

  3. Patients's satisfaction [ Time Frame: 2 weeks and 8 weeks ]
    good patients's satisfaction outcome by self-questionnaire


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02582762


Contacts
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Contact: Sumanas Bunyaratavej, MD 6624194333 consultskin@yahoo.com

Locations
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Thailand
Siriraj Hospital, Mahidol University Recruiting
Bangkok, Bangkoknoi, Thailand, 10700
Contact: Waranaree Winayanuwattikun, MD    664194333    wara.mim@gmail.com   
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Sumanas Bunyaratavej, MD Siriraj Hospital, Mahiidol University
More Information
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT02582762     History of Changes
Other Study ID Numbers: 658/2557(EC1)
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015
Keywords provided by Mahidol University:
Nail gel
Nail surface abnormality
Efficacy
Additional relevant MeSH terms:
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Congenital Abnormalities
Nails, Malformed
Pathological Conditions, Anatomical