Trial Outcomes & Findings for Administration of Oral Extended Release Minocycline for Assessment of Skin and Plasma Concentrations of Minocycline (NCT NCT02695446)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

12 participants

Primary outcome timeframe

Assessed at week 2 and week 4; reported at week 4

Results posted on

2017-09-14

Participant milestones
Measure	Oral ER Minocycline - Up to 2mg/kg Oral extended release minocycline - up to 2mg/kg once a day for 30 days. Minocycline: Oral extended release minocycline
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Administration of Oral Extended Release Minocycline for Assessment of Skin and Plasma Concentrations of Minocycline

Baseline characteristics by cohort
Measure	Oral ER Minocycline - Up to 2mg/kg n=12 Participants Oral extended release minocycline - up to 2mg/kg once a day for 30 days. Minocycline: Oral extended release minocycline
Age, Continuous	17 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants
Plasma Minocycline (ng/ml)	0 ng/ml n=5 Participants

Timeframe: Assessed at week 2 and week 4; reported at week 4

Outcome measures
Measure	Oral ER Minocycline - Up to 2mg/kg n=12 Participants Oral extended release minocycline - up to 2mg/kg once a day for 30 days. Minocycline: Oral extended release minocycline
Plasma Minocycline Level	421 ng/ml Standard Deviation 244

Timeframe: Measured at 2 weeks in half the subjects, 4 week biopsies not performed per early stopping rules

Outcome measures
Measure	Oral ER Minocycline - Up to 2mg/kg n=6 Participants Oral extended release minocycline - up to 2mg/kg once a day for 30 days. Minocycline: Oral extended release minocycline
Skin/Dermal Levels of Minocycline	0 ng/ml Interval 0.0 to 0.0

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Oral ER Minocycline - Up to 2mg/kg n=12 participants at risk Oral extended release minocycline - up to 2mg/kg once a day for 30 days. Minocycline: Oral extended release minocycline
Respiratory, thoracic and mediastinal disorders Upper Respiratory Infection	8.3% 1/12 • Number of events 1 • 6 weeks

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