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

NCT ID: NCT02582762

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-06-30

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).

Conditions

Nail Abnormalities

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nail gel

apply nail gel twice daily

Group Type: EXPERIMENTAL

Nail gel

Intervention Type: DRUG

apply nail gel on affected nails twice daily for 2 months

Interventions

Nail gel

apply nail gel on affected nails twice daily for 2 months

Intervention Type: DRUG

Other Intervention Names

Locycare

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sumanas Bunyaratavej, MD

Role: PRINCIPAL_INVESTIGATOR

Siriraj Hospital, Mahiidol University

Locations

Siriraj Hospital, Mahidol University

Bangkok, Bangkoknoi, Thailand

Site Status: RECRUITING

Countries

Thailand

Central Contacts

Sumanas Bunyaratavej, MD

Role: CONTACT

consultskin@yahoo.com

6624194333

Facility Contacts

Waranaree Winayanuwattikun, MD

Role: primary

wara.mim@gmail.com

664194333

Other Identifiers

658/2557(EC1)

Identifier Type: -

Identifier Source: org_study_id