Clinical trial NCT02404285: A Study to Evaluate the Clinical Effect of Daily Next Science™ Acne Gel (NAG) on Mild to Moderate Facial Acne
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Next Science TM
Sponsor class: INDUSTRY
Collaborators: name: Jacksonville Center For Clinical Research
name: St. Johns Center for Clinical Research
name: Fleming Island Center for Clinical Research
First posted: 2015-03-31
Enrollment: 68
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use.
timeFrame: Baseline until 12 weeks
Secondary outcomes:
measure: Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment.
timeFrame: 12 weeks
measure: Final Investigator Global Assessment Score With Daily Use of NAG Compared With Vehicle After 12-weeks.
timeFrame: Baseline until 12 weeks
measure: Change in Erythema Scores With Daily Use of NAG Compared With Vehicle After 12-weeks.
timeFrame: Baseline until 12 weeks
measure: Change in Dryness With Daily Use of NAG Compared With Vehicle After 12-weeks.
timeFrame: Baseline until 12 weeks
measure: Change in Burning/Stinging With Daily Use of NAG Compared With Vehicle After 12-weeks.
timeFrame: Baseline until 12 weeks
measure: Change in Erosion With Daily Use of NAG Compared With Vehicle After 12-weeks.
timeFrame: Baseline until 12 weeks
measure: Change in Edema With Daily Use of NAG Compared With Vehicle After 12-weeks.
timeFrame: Baseline until 12 weeks
measure: Change in Pain With Daily Use of NAG Compared With Vehicle After 12-weeks.
timeFrame: Baseline until 12 weeks
measure: Change in Itching With Daily Use of NAG Compared With Vehicle After 12-weeks.
timeFrame: Baseline until 12 weeks
Other outcomes:
measure: Change in Quality of Life - Self Perception With Daily Use of NAG Compared With Vehicle After 12-weeks.
timeFrame: Baseline until 12 weeks
measure: Change in Quality of Life - Role Emotional With Daily Use of NAG Compared With Vehicle After 12-weeks.
timeFrame: Baseline until 12 weeks
measure: Change in Quality of Life - Perceived Acne Symptoms With Daily Use of NAG Compared With Vehicle After 12-weeks.
timeFrame: Baseline until 12 weeks
measure: Change in Quality of Life - Role Social With Daily Use of NAG Compared With Vehicle After 12-weeks.
timeFrame: Baseline until 12 weeks
Locations:
city: Jacksonville
country: United States
facility: Fleming Island Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Ponte Vedra
country: United States
facility: St. Johns Center for Clinical Research
state: Florida
Study officials:
affiliation: Jacksonville Center For Clinical Research
name: Susan Greco, MD
role: STUDY_DIRECTOR
affiliation: Fleming Island Center for Clinical Research
name: Annabelle Matias, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St John's Center for Clinical Research
name: Lara Church, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernhardt MJ, Myntti MF. Topical Treatment With an Agent Disruptive to <em>P. acnes</em> Biofilm Provides Positive Therapeutic Response: Results of a Randomized Clinical Trial. J Drugs Dermatol. 2016 Jun 1;15(6):677-83.