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
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|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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
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
|Contact: Sumanas Bunyaratavej, MDfirstname.lastname@example.org|
|Siriraj Hospital, Mahidol University||Recruiting|
|Bangkok, Bangkoknoi, Thailand, 10700|
|Contact: Waranaree Winayanuwattikun, MD 664194333 email@example.com|
|Principal Investigator:||Sumanas Bunyaratavej, MD||Siriraj Hospital, Mahiidol University|