Trial Outcomes & Findings for Demodex Blepharitis Treatment Study (NCT NCT01647217)

Results Overview

Change in mites count after treatment compared to the baseline data. If the mites' count remains zero during the last two visits, it is considered "complete eradication". Patients without achieving complete eradication will be categorized as "incomplete eradication".

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

17 participants

Primary outcome timeframe

6 weeks

Results posted on

2017-07-26

Participant Flow

Participant milestones

Participant milestones
Measure	Placepo Pads Contol Arm 9 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 / 4 patients) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs. Placebo: Lid scrub once or twice per day for one month	Terpinen-4-ol Treatment Arm 8 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (3 / 5 patients) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs. Terpinen-4-ol: Lid scrub once or twice per day for one month.
Overall Study STARTED	9	8
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Demodex Blepharitis Treatment Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Terpinen-4-ol Treatment Arm n=8 Participants 8 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (3 / 5 patients) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs. Terpinen-4-ol: Lid scrub once or twice per day for one month.	Placepo Pads Contol Arm n=9 Participants 9 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 / 4 patients) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs. Placebo: Lid scrub once or twice per day for one month	Total n=17 Participants Total of all reporting groups
Age, Continuous	48.6 Years STANDARD_DEVIATION 21.2 • n=5 Participants	49 Years STANDARD_DEVIATION 18.5 • n=7 Participants	48.8 Years STANDARD_DEVIATION 19.1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	9 participants n=7 Participants	17 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Change in mites count after treatment compared to the baseline data. If the mites' count remains zero during the last two visits, it is considered "complete eradication". Patients without achieving complete eradication will be categorized as "incomplete eradication".

Outcome measures

Outcome measures
Measure	Terpinen-4-ol Treatment Arm n=7 Participants 10 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (5 patients each) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs. Terpinen-4-ol: Lid scrub once or twice per day for one month.	Placepo Pads Contol Arm n=8 Participants 10 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 each) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs. Placebo: Lid scrub once or twice per day for one month
Change in the Number of Demodex Mites	-3 Mites Standard Deviation 3.1	-0.4 Mites Standard Deviation 3.6

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Lid margin redness and bulbar conjunctival hyperemia were each assessed using an ordered categorical value ranging from 0 (None) to 3 (Severe). The two scores were summed to obtain the final score, which ranges from 0 (None) to 6 (Severe).

Outcome measures

Outcome measures
Measure	Terpinen-4-ol Treatment Arm n=7 Participants 10 patients will be randomized into the Study Group and will be subdivided into 2 subgroups (5 patients each) according to the treatment regimen (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs. Terpinen-4-ol: Lid scrub once or twice per day for one month.	Placepo Pads Contol Arm n=8 Participants 10 patients will be randomized into the control group and will be treated with placebo pads. They will be divided into 2 subgroups (5 each) according to the frequency (once or twice per day). Changes in the mite counts will be correlated with changes in symptoms and signs. Placebo: Lid scrub once or twice per day for one month
Change in Lid Margin Redness and Bulbar Conjunctival Hyperemia	-2.3 units on a scale Standard Deviation 1.4	-3.1 units on a scale Standard Deviation 1.9

Adverse Events

Terpinen-4-ol Treatment Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placepo Pads Contol Arm

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

Hosam El Sheha, MD, PhD

Tissuetech Inc

Phone: 305-274-1299

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place