A Study to Evaluate the Clinical Effect of Daily Next Science™ Acne Gel (NAG) on Mild to Moderate Facial Acne
Status: | Completed |
---|---|
Conditions: | Acne, Acne, Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 12 - Any |
Updated: | 3/31/2019 |
Start Date: | March 2015 |
End Date: | September 2015 |
A Multi-center, Double-blind, Vehicle-controlled Study to Evaluate the Clinical Effect of Daily Next Science™ Acne Gel (NAG) on Mild to Moderate Facial Acne
This is a 12 week, multi-site, double-blind, vehicle-controlled study in subjects with mild
to moderate facial acne. Subjects will be randomized 1:1 to apply either topical NAG or
vehicle gel daily. Subjects will be evaluated for clinical acne and quality of life outcomes
at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks.
to moderate facial acne. Subjects will be randomized 1:1 to apply either topical NAG or
vehicle gel daily. Subjects will be evaluated for clinical acne and quality of life outcomes
at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks.
Sample Size: N= 60 completed subjects Male and female subjects 12 years or older diagnosed
with mild to moderate inflammatory facial acne vulgaris.
Subjects will be treated with once daily topical NAG or matching vehicle and will attend
screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:
1. Lesion counts with photography
2. Investigator Global Assessment
3. Acne Quality of Life Questionnaire
4. Treatment Area Assessment by Investigator
Subjects will discontinue all baseline topical acne treatments with a 2 week washout and/or
all systemic acne treatments with a 3 week washout. All subjects will be provided open label
Cetaphil facial cleanser and double-blind NAG or vehicle product.
with mild to moderate inflammatory facial acne vulgaris.
Subjects will be treated with once daily topical NAG or matching vehicle and will attend
screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:
1. Lesion counts with photography
2. Investigator Global Assessment
3. Acne Quality of Life Questionnaire
4. Treatment Area Assessment by Investigator
Subjects will discontinue all baseline topical acne treatments with a 2 week washout and/or
all systemic acne treatments with a 3 week washout. All subjects will be provided open label
Cetaphil facial cleanser and double-blind NAG or vehicle product.
Inclusion Criteria:
1. Male or female ages 12 and above
2. Has 10 or more inflammatory lesions on the face (papules and pustules) as determined
by qualified examiner at Start of Treatment.
3. In the area to be treated, has no significant facial dermatological conditions other
than acne (as determined by the investigator) that would interfere with any study
treatment or procedure
4. Is willing and able to discontinue use of all baseline acne treatments for the
duration of their trial participation
5. Agrees to refrain from professional facial treatments during their trial
participation.
6. Agrees to avoid tanning booth use and minimize sun exposure during their trial
participation.
7. Is willing and able to follow instructions and procedures including attending
scheduled study visits, which will require adequate transportation to the study site
8. Is able to read, understand and sign the informed consent document and communicate
with study staff and investigator. If the subject is a minor, the parent or documented
legal guardian must meet these consent requirements and the subject must be able to
understand, agree to, and sign the assent form.
Exclusion Criteria:
1. Has more than 2 nodules/cystic acne lesions on the face
2. Has a history of significant reactions to topical acne treatments, or a known allergy
or hypersensitivity to any listed ingredients
3. Has any history of skin malignancy
4. Has significant facial hair that would interfere with evaluation of acne lesions or
global assessment.
5. Has used any systemic medications (including antibiotics, estrogens, retinoids)
primarily for treatment of acne in the 21 days prior to randomization.
6. Has used estrogens primarily as treatment for acne in the 21 days prior to
randomization (estrogens prescribed for other reasons will be allowed if stable for at
least 30 days prior to randomization).
7. Has had any professional facial treatments in the 14 days prior to randomization.
8. Has received any investigational treatment in the 30 days prior to randomization.
9. Have any significant medical problems or other issues that would, in the
investigator's judgment, affect their suitability for participation in this trial.
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