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

Primary Purpose

Nail Abnormalities

Status

Unknown status

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

Nail gel

About this trial

This is an interventional treatment trial for Nail Abnormalities focused on measuring Nail gel, Nail surface abnormality, Efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Siriraj Hospital, Mahidol UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Nail gel

Arm Description

apply nail gel twice daily

Outcomes

Primary Outcome Measures

Improvement overall nail surface abnormalities

Number of nails of each participant with change/improvement nail surface using clinical assessment

Secondary Outcome Measures

Improvement roughness of nail surface abnormalities

Number of nails of each participant with change/improvement nail surface using bioengineering measurement

Increase nail hydration

Number of nails of each participant with the increase of nail hydration using bioengineering measurement

Patients's satisfaction

good patients's satisfaction outcome by self-questionnaire

Full Information

NCT ID

NCT02582762

First Posted

October 18, 2015

Last Updated

October 19, 2015

Sponsor

Mahidol University

1. Study Identification

Unique Protocol Identification Number

NCT02582762

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2015

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

March 2016 (Anticipated)

Study Completion Date

June 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mahidol University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nail Abnormalities

Keywords

Nail gel, Nail surface abnormality, Efficacy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Nail gel

Arm Type

Experimental

Arm Description

apply nail gel twice daily

Intervention Type

Drug

Intervention Name(s)

Nail gel

Other Intervention Name(s)

Locycare

Intervention Description

apply nail gel on affected nails twice daily for 2 months

Primary Outcome Measure Information:

Title

Improvement overall nail surface abnormalities

Description

Number of nails of each participant with change/improvement nail surface using clinical assessment

Time Frame

2 weeks and 8 weeks

Secondary Outcome Measure Information:

Title

Improvement roughness of nail surface abnormalities

Description

Number of nails of each participant with change/improvement nail surface using bioengineering measurement

Time Frame

2 weeks, and 8 weeks

Title

Increase nail hydration

Description

Number of nails of each participant with the increase of nail hydration using bioengineering measurement

Time Frame

2 weeks, and 8 weeks

Title

Patients's satisfaction

Description

good patients's satisfaction outcome by self-questionnaire

Time Frame

2 weeks and 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sumanas Bunyaratavej, MD

Phone

6624194333

consultskin@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sumanas Bunyaratavej, MD

Organizational Affiliation

Siriraj Hospital, Mahiidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Siriraj Hospital, Mahidol University

City

Bangkok

State/Province

Bangkoknoi

ZIP/Postal Code

10700

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Waranaree Winayanuwattikun, MD

Phone

664194333

wara.mim@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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