Acne
Conditions
Brief summary
The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.
Detailed description
Not required
Interventions
DRUGTretinoin microsphere 0.1%
Treatment of acne vulgaris
DRUGBrand Retin-A Micro tretinoin microsphere gel 0.1%
Treatment of acne vulgaris
DRUGplacebo microsphere gel
treatment of acne vulgaris
Sponsors
Spear Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal, healthy male and female children and adult * Written and verbal informed consent must be obtained. Patients age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent. * Women of child-bearing potential must be non-pregnant and non-nursing, and must be willing to avoid pregnancy during the course of the study and during the menstrual cycle following completion of their participation in the study. * Able to refrain from the use of all other topical acne medications or antibiotics during the treatment period. * Considered reliable and capable of understanding their responsibility and role in the study.
Exclusion criteria
* Significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematological, hepatic, neurological, pancreatic, or renal disease. * Abnormal pre-existing skin condition which might affect the normal course of acne vulgaris (e.g., eczema, psoriasis, albinism, or chronic vesiculobullous disorders). * Use topical acne therapy during the two week period prior to study initiation. * Use of systemic retinoid treatment within six months prior to study initiation. * Pregnant or breast-feeding. * Serious psychological illness. * Participation in any clinical research study during the 30 day period preceding study initiation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Acne | 12 weeks | Counting of acne lesions both inflammatory and non-inflammatory |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Generic Tretinoin Microsphere Gel 0.1% | 205 |
| Brand Retin-A Micro 0.1% | 209 |
| Placebo Microsphere Gel no active | 66 |
| Total | 480 |
Baseline characteristics
| Characteristic | Brand | Placebo | Generic | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 100 Participants | 33 Participants | 100 Participants | 233 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 109 Participants | 33 Participants | 105 Participants | 247 Participants |
| Age, Continuous | 21 years STANDARD_DEVIATION 8.1 | 19 years STANDARD_DEVIATION 6.7 | 21 years STANDARD_DEVIATION 7.4 | 21 years STANDARD_DEVIATION 7.5 |
| Region of Enrollment United States | 209 participants | 66 participants | 205 participants | 480 participants |
| Sex: Female, Male Female | 150 Participants | 42 Participants | 150 Participants | 342 Participants |
| Sex: Female, Male Male | 59 Participants | 24 Participants | 55 Participants | 138 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 26 / 205 | 29 / 209 | 10 / 66 |
| serious Total, serious adverse events | 0 / 205 | 0 / 209 | 0 / 66 |
Outcome results
Primary
Improvement in Acne
Counting of acne lesions both inflammatory and non-inflammatory
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Generic | Improvement in Acne | -74 Percent change | Standard Deviation 0.05 |
| Brand | Improvement in Acne | -76 Percent change | Standard Deviation 0.04 |
| Placebo | Improvement in Acne | -58 Percent change | Standard Deviation 0.03 |