- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02582762
Pilot Study of Efficacy of Nail Gel in Finger Nail Surface Abnormality
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.
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Sumanas Bunyaratavej, MD
- Phone Number: 6624194333
- Email: consultskin@yahoo.com
Study Locations
-
-
Bangkoknoi
-
Bangkok, Bangkoknoi, Thailand, 10700
- Recruiting
- Siriraj Hospital, Mahidol University
-
Contact:
- Waranaree Winayanuwattikun, MD
- Phone Number: 664194333
- Email: wara.mim@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 18 years old or above
- Being diagnosed nail surface abnormalities stably more than 3 months
Exclusion Criteria:
- Having severe or uncontrolled concomitant diseases
- Having nail infection
- History of manicure within the last 1 month
- Use of Biotin or other nail modifying drugs within the previous 3 months
- Pregnancy or lactation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nail gel
apply nail gel twice daily
|
apply nail gel on affected nails twice daily for 2 months
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
2 weeks and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 weeks, and 8 weeks
|
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
|
2 weeks, and 8 weeks
|
Patients's satisfaction
Time Frame: 2 weeks and 8 weeks
|
good patients's satisfaction outcome by self-questionnaire
|
2 weeks and 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sumanas Bunyaratavej, MD, Siriraj Hospital, Mahiidol University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 658/2557(EC1)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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