Clinical trial NCT03106766: Six Months Evaluation of Next Science Acne Creams on Facial Acne in Adult Females.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Next Science TM
Sponsor class: INDUSTRY
Collaborators: name: Skin Laser & Surgery Specialists
First posted: 2017-04-10
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction in Lesion Count
timeFrame: Baseline versus 6 months
Secondary outcomes:
measure: Inflammatory Lesion count over time
timeFrame: weeks 6, 12, 18, and 24
measure: Non-inflammatory acne lesion over time
timeFrame: weeks 6, 12, 18, and 24
measure: Investigator Global Assessment over time
timeFrame: weeks 6, 12, 18, and 24
measure: Treatment Areas over time
timeFrame: weeks 6, 12, 18, and 24
measure: Quality of Life over time
timeFrame: weeks 6, 12, 18, and 24
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Skin Laser & Surgery Specialists of NY & NJ
state: New Jersey
Study officials:
affiliation: Next Science
name: Matt Myntti, PhD
role: STUDY_DIRECTOR
References: