Trial Outcomes & Findings for Study Evaluating the Effect of Jublia on Dermatophytomas (NCT NCT03098615)

NCT ID: NCT03098615

Last Updated: 2019-12-10

Results Overview

Clear nail growth between the proximal nail fold and the dermatophytoma's proximal edge will be measured.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 19 participants
• Primary outcome timeframe: week 48
• Results posted on: 2019-12-10

Participant Flow

Participant milestones

Measure	Jublia Treatment Group The intervention to be administered is Jublia (Efinaconazole 10% Topical Solution). The frequency of administration is daily to the affected toes.
Overall Study STARTED	19
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Evaluating the Effect of Jublia on Dermatophytomas

Baseline characteristics by cohort

Measure	Baseline Group n=19 Participants Subject with age \>18, provision of informed consent, presence of dermatophytoma on one or both great toenails, target great to-nail thickness \<= 3.0 mm, positive potassium hydroxide (KOH) or culture. Exclusion based upon history of immunosuppression, history of psoriasis of the nail, other nail disease, 3 or more dermatophytomas, unwillingness to avoid nail polish
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: week 48

Clear nail growth between the proximal nail fold and the dermatophytoma's proximal edge will be measured.

Outcome measures

Measure	Baseline Group n=19 Participants Subject with age \>18, provision of informed consent, presence of dermatophytoma on one or both great toenails, target great to-nail thickness \<= 3.0 mm, positive KOH or culture. Exclusion based upon history of immunosuppression, history of psoriasis of the nail, other nail disease, 3 or more dermatophytomas, unwillingness to avoid nail polish.
Number of Participants With Elimination of Dermatophytomas That Occur in Distal Lateral Subungual Onychomycosis (DLSO)	19 Participants

SECONDARY outcome

Timeframe: week 48

Completely normal nail plate or negative fungal culture

Outcome measures

Measure	Baseline Group n=19 Participants Subject with age \>18, provision of informed consent, presence of dermatophytoma on one or both great toenails, target great to-nail thickness \<= 3.0 mm, positive KOH or culture. Exclusion based upon history of immunosuppression, history of psoriasis of the nail, other nail disease, 3 or more dermatophytomas, unwillingness to avoid nail polish.
Clinical or Mycological Cure of Nail	12 Participants

Adverse Events

Baseline Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Leslie Roop

UAB

Phone: 2059754917

Email: lmroop@uabmc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place