Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
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.

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
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

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT02582762

Layout table for location contacts
Contact: Sumanas Bunyaratavej, MD 6624194333

Layout table for location information
Siriraj Hospital, Mahidol University Recruiting
Bangkok, Bangkoknoi, Thailand, 10700
Contact: Waranaree Winayanuwattikun, MD    664194333   
Sponsors and Collaborators
Mahidol University
Layout table for investigator information
Principal Investigator: Sumanas Bunyaratavej, MD Siriraj Hospital, Mahiidol University
Layout table for additonal information
Responsible Party: Mahidol University Identifier: NCT02582762    
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Congenital Abnormalities
Nails, Malformed
Pathological Conditions, Anatomical