A Clinical Trial to Evaluate the Efficacy of Two Acne Treatments
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Acne, Acne |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 21 - 45 |
| Updated: | 12/24/2016 |
| Start Date: | April 2016 |
| End Date: | April 2017 |
A Multi-Center Clinical Trial to Evaluate the Efficacy of Two Acne Treatments
The purpose of this study is to evaluate the efficacy of 2 acne treatments for 24 weeks of
use in adult men and women with mild to moderate facial acne, at least 5 inflammatory
lesions, and at least 10 - 100 non-inflammatory lesions.
Objective:
1. To characterize the effectiveness of the acne treatment in lesion count at week 1, week
2, week 6, week 12, and week 24 as compared to baseline and compare between treatments
2. To characterize the effectiveness of the acne treatment in Investigator's Global
Improvement Assessment at week 1, week 2, week 6, week 12, and week 24 as compared to
baseline and compare between treatments
3. To characterize the effect of the acne treatment in clinical grading of efficacy
parameters through digital images at week 6, week 12, and week 24 as compared to
baseline and compare between treatments
4. To characterize the effect of the acne treatment in subject self-assessment
questionnaire responses at week 1, week 2, week 6, week 12, and week 24 as compared to
baseline and compare between treatments
use in adult men and women with mild to moderate facial acne, at least 5 inflammatory
lesions, and at least 10 - 100 non-inflammatory lesions.
Objective:
1. To characterize the effectiveness of the acne treatment in lesion count at week 1, week
2, week 6, week 12, and week 24 as compared to baseline and compare between treatments
2. To characterize the effectiveness of the acne treatment in Investigator's Global
Improvement Assessment at week 1, week 2, week 6, week 12, and week 24 as compared to
baseline and compare between treatments
3. To characterize the effect of the acne treatment in clinical grading of efficacy
parameters through digital images at week 6, week 12, and week 24 as compared to
baseline and compare between treatments
4. To characterize the effect of the acne treatment in subject self-assessment
questionnaire responses at week 1, week 2, week 6, week 12, and week 24 as compared to
baseline and compare between treatments
Key Inclusion Criteria:
1. Men and women age 21 to 45 years at the time of enrollment.
2. Individuals with mild to moderate acne (score of 2-3 on FDA Investigator's Global
Assessment Scale1) on the face.
3. Individuals with at least 5 inflammatory lesions.
4. Individuals with 10 - 100 non-inflammatory lesions.
5. Fitzpatrick skin type I-VI
6. Individuals willing to provide written informed consent including photo release,
Health Insurance Portability and Accountability Act (HIPAA), and are able to read,
speak,write, understand English.
7. Willing to withhold all facial treatments during the course of the study
8. Individuals of child bearing potential who use an acceptable method of contraception
throughout the study.
9. Subjects must be stable on any medication they are taking for at least 30 days.
Key Exclusion Criteria:
1. Individuals diagnosed with allergies to topical acne products.
2. Individuals having a condition and/or disease of the skin that the Investigator deems
inappropriate for participation.
3. Women who are nursing, pregnant, or planning to become pregnant during the study.
4. Individuals who have pre-existing or dormant dermatologic conditions on the face
which in the opinion of the Investigator could interfere with the outcome of the
study.
5. Individuals using or who have used any systemic medication considered to affect the
course of acne, specifically, but not exclusively antibiotics or steroids within the
last 30 days prior to entry into the study.
6. Individuals who are currently participating in another facial usage study or have
participated in a clinical trial within 4 weeks prior to inclusion into the study.
7. Individuals with any planned surgeries and/or invasive medical procedures during the
course of the study.
8. Individuals who started hormone replacement therapies (HRT) or hormones for birth
control less than 3 months prior to study entry or who plan on starting, stopping, or
changing doses of HRT or hormones for birth control during the study.
9. Individuals with facial sunburn or excessive tanned facial skin or that are not
willing to avoid daily sun exposure on the face and the use of tanning beds or
sunless tanning products for the duration of the study.
10. Individuals that are currently taking or have taken within the last 30 days oral or
topical prescription medications for acne.
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