Acne Vulgaris
Conditions
Brief summary
This is a multi center open label study intended to provide photo documentation and time to response data for BPX-01 1 and 2% minocycline topical gel for the treatment of moderate to severe non-nodular inflammatory acne vulgarism.
Detailed description
This was a 12-week, multi-center, open label, two-arm study. Subjects will be assigned to treatment with 1% or 2% BPX-01 gel. Subjects will apply 1g of the gel as a thin film to the entire face at least 30 minutes before bedtime each night for 12 weeks. Lesion counts, IGA, and Patient-Reported Outcomes (PGI-S and PGI-I) will be performed to assess efficacy. Photographs will be taken to document treatment effect. Safety will be assessed with the vital signs, brief physical examination, clinical laboratory tests, cutaneous tolerance score, incidence of minocycline-induced skin hyperpigmentation, incidence of visual disturbances and/or headaches suggestive of pseudotumor cerebri, incidence of product related facial staining and collection of adverse events.
Interventions
DRUGMinocycline
BPX-01 1 or 2% topical gel will be applied to face once daily
Sponsors
BioPharmX, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
\- moderate to severe inflammatory non-nodular acne vulgaris
Exclusion criteria
* female subject who is breastfeeding, pregnant or planning a pregnancy during the study * have other skin condition or disease that would interfere with the study * have had any prior treatment with minocycline * have a known or suspected allergy to tetracycline class products * have used OTC medications for the treatment of facial acne within the last 14 days * have used any prescription topical or oral medications for the treatment of facial acne in the last 28 days * have had a facial procedure (chemical peel, dermabrasion, laser, etc) within the last 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Inflammatory Lesion Counts at Week 12 | 12 weeks | difference in number of inflammatory lesions at week 12 as compared to baseline |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BPX-01 1% BPX-01 1% minocycline topical gel
Minocycline: BPX-01 1 or 2% topical gel will be applied to face once daily at bedtime | 8 |
| BPX-01 2% BPX-01 2% minocycline topical gel
Minocycline: BPX-01 1 or 2% topical gel will be applied to face once daily at bedtime | 10 |
| Total | 18 |
Baseline characteristics
| Characteristic | BPX-01 1% | BPX-01 2% | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants | 10 Participants | 18 Participants |
| Age, Continuous | 25 years | 25 years | 25 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 7 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 9 Participants | 16 Participants |
| Region of Enrollment United States | 8 Participants | 10 Participants | 18 Participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 10 |
| other Total, other adverse events | 2 / 8 | 3 / 10 |
| serious Total, serious adverse events | 0 / 8 | 0 / 10 |
Outcome results
Primary
Change From Baseline in Inflammatory Lesion Counts at Week 12
difference in number of inflammatory lesions at week 12 as compared to baseline
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| BPX-01 1% | Change From Baseline in Inflammatory Lesion Counts at Week 12 | 22.3 inflammatory lesions |
| BPX-01 2% | Change From Baseline in Inflammatory Lesion Counts at Week 12 | 19.0 inflammatory lesions |