Acne
Conditions
Brief summary
The primary objective of this study is to evaluate the skin and plasma concentrations of minocycline in subjects undergoing treatment of acne vulgaris with oral extended release minocycline. Acne lesion counts and safety/tolerance of the treatment will also be evaluated.
Detailed description
This will be an open label, non randomized, interventional pilot study evaluating the plasma and skin levels of minocycline in 10 subjects with moderate to severe acne vulgaris. Subjects with non inflammatory acne of nodular acne will not be enrolled. Subjects will be on an oral extended release minocycline regimen of up to 2mg/kg once a day for 4 weeks. Steady state levels of minocycline in plasma and skin will be determined.
Interventions
DRUGMinocycline
Oral extended release minocycline
Sponsors
BioPharmX, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Otherwise healthy male and female subjects 14 to 40 years of age * Moderate to severe inflammatory facial acne vulgaris (EGSA score of 3-5) * Subjects not using oral or topical antibiotic products for at least 30 days prior to study entry and willing to refrain from use of oral and topical antibiotics for the duration of study participation * Subjects not currently using and willing to refrain from use of other topical acne products for the duration of study participation
Exclusion criteria
* Mild, non-inflammatory or nodular acne vulgaris * Have current or previous skin cancer * Have a history of skin disease or presence of skin condition the PI believes would interfere with the study * Females who report that they are pregnant, planning a pregnancy during the study period or breastfeeding * Have conditions or factors that the PI believes may affect the response of the skin or the interpretation of the results * Participation in any clinical study within the previous 30 days or plan concurrent participation in other studies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Plasma Minocycline Level | Assessed at week 2 and week 4; reported at week 4 |
Secondary
| Measure | Time frame |
|---|---|
| Skin/Dermal Levels of Minocycline | Measured at 2 weeks in half the subjects, 4 week biopsies not performed per early stopping rules |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Oral ER Minocycline - Up to 2mg/kg |
|---|---|
| Age, Continuous | 17 years |
| Plasma Minocycline (ng/ml) | 0 ng/ml |
| Region of Enrollment United States | 12 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 1 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Plasma Minocycline Level
Time frame: Assessed at week 2 and week 4; reported at week 4
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral ER Minocycline - Up to 2mg/kg | Plasma Minocycline Level | 421 ng/ml | Standard Deviation 244 |
Secondary
Skin/Dermal Levels of Minocycline
Time frame: Measured at 2 weeks in half the subjects, 4 week biopsies not performed per early stopping rules
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Oral ER Minocycline - Up to 2mg/kg | Skin/Dermal Levels of Minocycline | 0 ng/ml |