Clinical Trial: Pilot Study of Efficacy of Nail Gel in Finger Nail Surface Abnormality

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 Summary:

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).


Sponsor: Mahidol University

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Mahidol University

Dates:
Date Received: October 18, 2015
Date Started: September 2015
Date Completion: June 2016
Last Updated: October 19, 2015
Last Verified: October 2015