Six Months Evaluation of Next Science Acne Creams on Facial Acne in Adult Females.

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Single-center, Double-blind, Controlled Study to Evaluate the Effect of Next Science™ Acne Cream on Mild to Moderate Facial Acne in Adult Females Over 6 Months.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Acne cream 2X
* Drug: Acne cream 1X


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female ages 18 and above Has 20 or more inflammatory lesions on the face (papules and pustules) as determined by qualified examiner at Start of Treatment. 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 Is willing and able to discontinue use of all baseline acne treatments for the duration of their trial participation Agrees to refrain from professional facial treatments during their trial participation. Agrees to avoid tanning booth use and minimize sun exposure during their trial participation. Is willing and able to follow instructions and procedures including attending scheduled study visits, which will require adequate transportation to the study site Is able to read, understand and sign the informed consent document and communicate with study staff and investigator. Exclusion Criteria: Has more than 2 nodules/cystic acne lesions on the face Has a history of significant reactions to topical acne treatments, or a known allergy or hypersensitivity to any listed ingredients Has any history of skin malignancy Has used any systemic medications (including antibiotics, estrogens, retinoids) primarily for treatment of acne in the 21 days prior to randomization. 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). Has had any professional facial treatments in the 14 days prior to randomization. Has received any investigational treatment in the 30 days prior to randomization. Have any significant medical problems or other issues that would, in the investigator's judgment, affect their suitability for participation in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acne cream 1x<br>Twice-daily facial applications of the 1X product (avoiding contact with eyes and all mucous membranes) to the entire face for 6 months. | Drug: Acne cream 1X<br>* Twice daily application of facial acne cream 1X after facial cleansing<br>|
| Experimental: Acne cream 2x<br>Twice-daily facial applications of the 2X product (avoiding contact with eyes and all mucous membranes) to the entire face for 6 months. | Drug: Acne cream 2X<br>* Twice daily application of facial acne cream 2X after facial cleansing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Lesion Count | 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. | Baseline versus 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory Lesion count over time | to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 inflammatory lesion counts | weeks 6, 12, 18, and 24 | 
| Non-inflammatory acne lesion over time | to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in non-inflammatory lesion counts | weeks 6, 12, 18, and 24 | 
| Investigator Global Assessment over time | to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in IGA | weeks 6, 12, 18, and 24 | 
| Treatment Areas over time | 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) | weeks 6, 12, 18, and 24 | 
| Quality of Life over time | 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. | weeks 6, 12, 18, and 24 |