Nail Abnormalities Clinical Trial
Official title:
Pilot Study of Efficacy of Nail Gel Containing Artemisia Abrotanum Extract and Glycerin in Finger Nail Surface Abnormality
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.
| Status | Recruiting |
| Enrollment | 20 |
| Est. completion date | June 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Siriraj Hospital, Mahidol University | Bangkok | Bangkoknoi |
| Lead Sponsor | Collaborator |
|---|---|
| Mahidol University |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improvement overall nail surface abnormalities | Number of nails of each participant with change/improvement nail surface using clinical assessment | 2 weeks and 8 weeks | No |
| Secondary | Improvement roughness of nail surface abnormalities | Number of nails of each participant with change/improvement nail surface using bioengineering measurement | 2 weeks, and 8 weeks | No |
| Secondary | Increase nail hydration | Number of nails of each participant with the increase of nail hydration using bioengineering measurement | 2 weeks, and 8 weeks | No |
| Secondary | Patients's satisfaction | good patients's satisfaction outcome by self-questionnaire | 2 weeks and 8 weeks | No |