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

Mahidol University

Status and phase: Unknown; Phase 3

Conditions: Nail Abnormalities

Treatments: Drug: Nail gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02582762

658/2557(EC1)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Nail gel

Experimental group

Description:

apply nail gel twice daily

Treatment:

Drug: Nail gel