Real-World Evaluation of the Effect of Jublia on Nail Polish

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The University of Alabama at Birmingham

Status

Completed

Conditions

Evaluation of Jublia on Nail Polish With Healthy Toenails

Treatments

Drug: Nail Polish + Top Coat + Efinaconazole Solution
Drug: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution
Drug: Nail Polish + Efinaconazole Solution
Other: Nail polish

Study type

Interventional

Funder types

Other

Identifiers

NCT03022916
X150817005

Details and patient eligibility

About

A recent publication using cadaver nails suggests that Jublia application has a negative effect on nail polish texture.

Full description

It is believed that investigating the affect of Jublia is an important question with regards to how it affects how various nail polished and top coats will be used.

Enrollment

5 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Exhibit distal lateral subungual onychomycosis (DLSO)
  • Has the informed consent been signed and patient's questions answered.
  • Age ≥ 18
  • Patient willing and able to participate for the full duration of the study
  • No onychomycosis
  • Greater than 4 weeks from prior major surgery for any indication

Willing to abstain from:

  • The application of other topical medications or cosmetic products to the toenail
  • Professional pedicures for the duration of the study.

Females of childbearing potential must:

  • Have been using adequate contraception (abstinence, IUD, birth control pills or spermicidal gel with diaphragm or condom) since their last menses
  • Agree to continue using adequate means of contraception (abstinence, IUD, birth control pills or spermicidal gel with diaphragm or condom) for the duration of study participation
  • Females are not considered to be of childbearing potential if they are at least 1 year postmenopausal or have had a tubal ligation, bilateral oophorectomy or hysterectomy.

Exclusion criteria

  • Active onychomycosis of the toenails or fingernails

Any of the following in the 4 weeks (or as indicated) prior to randomization:

  • Major surgery for any indication

Any personal history of:

  • Invasive cancer diagnosed or treated within the past 5 years. Participants who have been in remission for 5 years or more and have not required treatment in the past 5 years may be eligible if the principal investigator believes there is little to no risk of recurrence.
  • Concurrent use of the following medications or treatments
  • Other topical antifungals for any concomitant infection
  • Females who are pregnant or lactating. Should a woman become pregnant or suspect she is pregnant while she is participating in this study she should notify the study physician immediately.
  • Uncontrolled concurrent illness including ongoing or active infection, psychiatric illness or social situations that would limit compliance with study requirements or other underlying serious medical condition which, in the investigator's opinion, might preclude study participation.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

5 participants in 4 patient groups, including a placebo group

Nail Polish + Efinaconazole Solution
Active Comparator group
Description:
One big toe will receive application of Efinaconazole Solution on top of nail polish (without the presence of a top coat or base coat)
Treatment:
Drug: Nail Polish + Efinaconazole Solution
Nail Polish Only
Placebo Comparator group
Description:
Both big toes will use nail polish only
Treatment:
Other: Nail polish
Base Coat + Nail Polish + Top Coat + Efinaconazole Solution
Active Comparator group
Description:
One big toe will receive application of Efinaconazole solution on top of nail polish with base coat and top coat.
Treatment:
Drug: Base Coat + Nail Polish + Top Coat + Efinaconazole Solution
Nail Polish + Top Coat + Efinaconazole Solution
Active Comparator group
Description:
One big toe will receive application of Efinaconazole solution on top of nail polish with top coat.
Treatment:
Drug: Nail Polish + Top Coat + Efinaconazole Solution

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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