Back to resultsA Study to Evaluate the Clinical Effect of Daily Next Science™ Acne Gel (NAG) on Mild to Moderate Facial Acne
Primary Purpose
Acne Vulgaris
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Next Science Acne Gel
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Male or female ages 12 and above
- Has 10 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. 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:
- 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 significant facial hair that would interfere with evaluation of acne lesions or global assessment.
- 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.
Sites / Locations
- Fleming Island Center for Clinical Research
- Jacksonville Center for Clinical Research
- St. Johns Center for Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Vehicle
NAG (Next Science Acne Gel)
Arm Description
Subjects will be treated with once daily vehicle and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed: Lesions will be counted and right, left and forward facing photographs will be taken Investigator Global Assessment Acne Quality of Life Questionnaire Treatment Area Assessment by Investigator
Subjects will be treated with once daily NAG and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed: Lesions will be counted and right, left and forward facing photographs will be taken Investigator Global Assessment Acne Quality of Life Questionnaire Treatment Area Assessment by Investigator
Outcomes
Primary Outcome Measures
Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use.
Percent change in number of Inflammatory lesions with daily use of NAG compared with vehicle after 12-weeks of use.
Secondary Outcome Measures
Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment.
Percent Change in Number of Non-inflammatory lesions (open and closed comedones) were counted after 12 weeks of either Vehicle of NAG treatment
Final Investigator Global Assessment Score With Daily Use of NAG Compared With Vehicle After 12-weeks.
Change in Investigator Global Assessment (IGA) score (0-5) with daily use of NAG compared with vehicle after 12-weeks. IGA score is worse at 5, with improvement at lower scores (best at 0).
Change in Erythema Scores With Daily Use of NAG Compared With Vehicle After 12-weeks.
Change in Erythema (measure of redness) scores with daily use of NAG compared with vehicle after 12-weeks.Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Change in Dryness With Daily Use of NAG Compared With Vehicle After 12-weeks.
Change in Dryness score with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Change in Burning/Stinging With Daily Use of NAG Compared With Vehicle After 12-weeks.
Change in Burning/Stinging scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Change in Erosion With Daily Use of NAG Compared With Vehicle After 12-weeks.
Change in Erosion scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Change in Edema With Daily Use of NAG Compared With Vehicle After 12-weeks.
Change in Edema scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Change in Pain With Daily Use of NAG Compared With Vehicle After 12-weeks.
Change in Pain scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Change in Itching With Daily Use of NAG Compared With Vehicle After 12-weeks.
Change in Itching scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Full Information
NCT ID
NCT02404285
First Posted
March 13, 2015
Last Updated
March 7, 2019
Sponsor
Next Science TM
Collaborators
Jacksonville Center For Clinical Research, St. Johns Center for Clinical Research, Fleming Island Center for Clinical Research
1. Study Identification
Unique Protocol Identification Number
NCT02404285
Brief Title
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
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Next Science TM
Collaborators
Jacksonville Center For Clinical Research, St. Johns Center for Clinical Research, Fleming Island Center for Clinical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
Lesion counts with photography
Investigator Global Assessment
Acne Quality of Life Questionnaire
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Subjects will be treated with once daily vehicle and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:
Lesions will be counted and right, left and forward facing photographs will be taken
Investigator Global Assessment
Acne Quality of Life Questionnaire
Treatment Area Assessment by Investigator
Arm Title
NAG (Next Science Acne Gel)
Arm Type
Active Comparator
Arm Description
Subjects will be treated with once daily NAG and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:
Lesions will be counted and right, left and forward facing photographs will be taken
Investigator Global Assessment
Acne Quality of Life Questionnaire
Treatment Area Assessment by Investigator
Intervention Type
Drug
Intervention Name(s)
Next Science Acne Gel
Other Intervention Name(s)
NAG
Intervention Description
Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.
Primary Outcome Measure Information:
Title
Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use.
Description
Percent change in number of Inflammatory lesions with daily use of NAG compared with vehicle after 12-weeks of use.
Time Frame
Baseline until 12 weeks
Secondary Outcome Measure Information:
Title
Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment.
Description
Percent Change in Number of Non-inflammatory lesions (open and closed comedones) were counted after 12 weeks of either Vehicle of NAG treatment
Time Frame
12 weeks
Title
Final Investigator Global Assessment Score With Daily Use of NAG Compared With Vehicle After 12-weeks.
Description
Change in Investigator Global Assessment (IGA) score (0-5) with daily use of NAG compared with vehicle after 12-weeks. IGA score is worse at 5, with improvement at lower scores (best at 0).
Time Frame
Baseline until 12 weeks
Title
Change in Erythema Scores With Daily Use of NAG Compared With Vehicle After 12-weeks.
Description
Change in Erythema (measure of redness) scores with daily use of NAG compared with vehicle after 12-weeks.Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Time Frame
Baseline until 12 weeks
Title
Change in Dryness With Daily Use of NAG Compared With Vehicle After 12-weeks.
Description
Change in Dryness score with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Time Frame
Baseline until 12 weeks
Title
Change in Burning/Stinging With Daily Use of NAG Compared With Vehicle After 12-weeks.
Description
Change in Burning/Stinging scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Time Frame
Baseline until 12 weeks
Title
Change in Erosion With Daily Use of NAG Compared With Vehicle After 12-weeks.
Description
Change in Erosion scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Time Frame
Baseline until 12 weeks
Title
Change in Edema With Daily Use of NAG Compared With Vehicle After 12-weeks.
Description
Change in Edema scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Time Frame
Baseline until 12 weeks
Title
Change in Pain With Daily Use of NAG Compared With Vehicle After 12-weeks.
Description
Change in Pain scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Time Frame
Baseline until 12 weeks
Title
Change in Itching With Daily Use of NAG Compared With Vehicle After 12-weeks.
Description
Change in Itching scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence).
Time Frame
Baseline until 12 weeks
Other Pre-specified Outcome Measures:
Title
Change in Quality of Life - Self Perception With Daily Use of NAG Compared With Vehicle After 12-weeks.
Description
Change in Self Perception scores with daily use of NAG compared with vehicle after 12-weeks. The Acne Quality of Life (QoL) Questionnaire Form was used to determine the practical improvements in quality of life. The Acne-QoL form is a validated measure that contains 19 questions referring to the past week, organized into four area: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives.
Time Frame
Baseline until 12 weeks
Title
Change in Quality of Life - Role Emotional With Daily Use of NAG Compared With Vehicle After 12-weeks.
Description
Change in Role-Emotional scores with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives
Time Frame
Baseline until 12 weeks
Title
Change in Quality of Life - Perceived Acne Symptoms With Daily Use of NAG Compared With Vehicle After 12-weeks.
Description
Change in the subjects perception of their acne symptoms with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives
Time Frame
Baseline until 12 weeks
Title
Change in Quality of Life - Role Social With Daily Use of NAG Compared With Vehicle After 12-weeks.
Description
Change in subjects social response to their acne with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives
Time Frame
Baseline until 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female ages 12 and above
Has 10 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. 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:
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 significant facial hair that would interfere with evaluation of acne lesions or global assessment.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Greco, MD
Organizational Affiliation
Jacksonville Center For Clinical Research
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Annabelle Matias, MD
Organizational Affiliation
Fleming Island Center for Clinical Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lara Church, MD
Organizational Affiliation
St John's Center for Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fleming Island Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32203
Country
United States
Facility Name
Jacksonville Center for Clinical Research
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
St. Johns Center for Clinical Research
City
Ponte Vedra
State/Province
Florida
ZIP/Postal Code
32081
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
27272073
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.
Results Reference
result
Learn more about this trial
A Study to Evaluate the Clinical Effect of Daily Next Science™ Acne Gel (NAG) on Mild to Moderate Facial Acne
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