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
Acne study
Interventions
DRUGTretinoin
Treatment of acne
DRUGplacebo
treatment of acne
Sponsors
Spear Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
A subject will be eligible to participate if they meet all of the following inclusion criteria: * Normal, healthy male and female children and adults. * Age 12 to 40 years. * Written and verbal informed consent must be obtained. Subjects age 12 to 17 (inclusive) must sign an assent for the study and a parent or a legal guardian must sign the informed consent (per FDA letter 8.21.07). * 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, adequate contraception is defined as regular use of any two of the following: oral, injectable contraceptives, condoms, spermicides, diaphragm, IUD, implantable and contraceptive patches. (oral contraceptives if used for at least three months and injectable contraceptives if used for at least 6 months)- prior to enrollment in the study, or abstinence. * Have at least 20 inflammatory (papules and pustules) and 25 non-inflammatory (open and closed comedones) lesions with a maximum of 2 nodulocystic lesions on the face (per FDA letter 8.21.07). * Global severity score from 2-4 * 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
A subject will be eligible to participate if they meet none of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acne Lesion Percent Reduction | 12 week | Reduction in number of Acne lesions by counting over 12 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Generic Active generic group | 401 |
| Brand Brand group | 404 |
| Placebo Placebo group | 135 |
| Total | 940 |
Baseline characteristics
| Characteristic | Active Generic | Brand | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 17.2 years STANDARD_DEVIATION 6.2 | 17.1 years STANDARD_DEVIATION 6.1 | 17.6 years STANDARD_DEVIATION 6.3 | 17.2 years STANDARD_DEVIATION 6.2 |
| Region of Enrollment United States | 401 participants | 404 participants | 135 participants | 940 participants |
| Sex: Female, Male Female | 193 Participants | 211 Participants | 80 Participants | 484 Participants |
| Sex: Female, Male Male | 208 Participants | 193 Participants | 55 Participants | 456 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 | 0 / 401 | 0 / 135 | 0 / 404 |
| serious Total, serious adverse events | 1 / 401 | 0 / 135 | 1 / 404 |
Outcome results
Primary
Acne Lesion Percent Reduction
Reduction in number of Acne lesions by counting over 12 weeks
Time frame: 12 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active Generic | Acne Lesion Percent Reduction | -54.3 percent reduction of number of lesions | Standard Deviation 10 |
| Placebo | Acne Lesion Percent Reduction | -35 percent reduction of number of lesions | Standard Deviation 8 |
| Brand | Acne Lesion Percent Reduction | -53.5 percent reduction of number of lesions | Standard Deviation 10 |