Acne Vulgaris
Conditions
Brief summary
To assess facial acne vulgaris clinical and psychological outcomes by measuring differences in lesions counts, investigator global assessment, and subjects quality of life scores over 6 months in adult females treated with Next Science™ acne cream 2x or Next Science™ acne cream 1x in a double blind manner.
Detailed description
This is a 6-month, single-site, double-blind, controlled study in 20 female subjects with mild to moderate facial acne. Subjects will be randomized 1:1 to apply either topical Next Science™ acne cream 2x or Next Science™ acne cream 1x daily. Subjects will be evaluated for clinical acne and quality of life outcomes at baseline, 6, 12, 18 and 24 weeks.
Interventions
DRUGAcne cream 2X
Twice daily application of facial acne cream 2X after facial cleansing
DRUGAcne cream 1X
Twice daily application of facial acne cream 1X after facial cleansing
Sponsors
Skin Laser & Surgery Specialists
Next Science TM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female ages 18 and above 2. Has 20 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.
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 used any systemic medications (including antibiotics, estrogens, retinoids) primarily for treatment of acne in the 21 days prior to randomization. 5. 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). 6. Has had any professional facial treatments in the 14 days prior to randomization. 7. Has received any investigational treatment in the 30 days prior to randomization. 8. Have any significant medical problems or other issues that would, in the investigator's judgment, affect their suitability for participation in this trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Lesion Count | Baseline versus 6 months | Inflammatory acne lesions with both study acne cream products after 6 months of treatment compared to baseline. This will be measured as the mean percent change from baseline to week 24 in the inflammatory lesion count. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Lesion count over time | weeks 6, 12, 18, and 24 | to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 inflammatory lesion counts |
| Non-inflammatory acne lesion over time | weeks 6, 12, 18, and 24 | to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in non-inflammatory lesion counts |
| Investigator Global Assessment over time | weeks 6, 12, 18, and 24 | to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in IGA |
| Treatment Areas over time | weeks 6, 12, 18, and 24 | to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in treatment areas (erythema, dryness, stinging or burning, erosion, edema, pain and itching) |
| Quality of Life over time | weeks 6, 12, 18, and 24 | The Acne-QoL questionnaire containing 19 questions organized into four domains which address the impact of facial acne on health-related quality of life will be administered. These are Self Perception, Role-social, Role-emotional and Acne Symptoms. Results will assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in QoL. |
Countries
United States
Outcome results
None listed