Acne Vulgaris
Conditions
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.
Interventions
DRUGNext Science Acne Gel
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.
DRUGVehicle
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.
Sponsors
Jacksonville Center For Clinical Research
St. Johns Center for Clinical Research
Fleming Island Center for Clinical Research
Next Science TM
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use. | Baseline until 12 weeks | Percent change in number of Inflammatory lesions with daily use of NAG compared with vehicle after 12-weeks of use. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dryness With Daily Use of NAG Compared With Vehicle After 12-weeks. | Baseline until 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 Erosion With Daily Use of NAG Compared With Vehicle After 12-weeks. | Baseline until 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. | Baseline until 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. | Baseline until 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. | Baseline until 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). |
| Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment. | 12 weeks | 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. | Baseline until 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. | Baseline until 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 Burning/Stinging With Daily Use of NAG Compared With Vehicle After 12-weeks. | Baseline until 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life - Perceived Acne Symptoms With Daily Use of NAG Compared With Vehicle After 12-weeks. | Baseline until 12 weeks | 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 |
| Change in Quality of Life - Role Social With Daily Use of NAG Compared With Vehicle After 12-weeks. | Baseline until 12 weeks | 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 |
| Change in Quality of Life - Role Emotional With Daily Use of NAG Compared With Vehicle After 12-weeks. | Baseline until 12 weeks | 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 |
| Change in Quality of Life - Self Perception With Daily Use of NAG Compared With Vehicle After 12-weeks. | Baseline until 12 weeks | 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. |
Countries
United States
Participant flow
Pre-assignment details
Subjects were enrolled in the study after signing informed consent and meeting inclusion/exclusion criteria per protocol. A Washout period of 2-3 weeks was initiated for subjects discontinuing topical acne or systemic acne treatment respectively to normalize by washing their face twice a day with the study facial cleansing soap.
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Subjects were treated with once daily vehicle and attended screening, randomization, 2,4,8 and 12 week visits. The following was assessed:
1. Lesions were counted and right, left and forward facing photographs were taken
2. Investigator Global Assessment
3. Acne Quality of Life Questionnaire
4. Treatment Area Assessment by Investigator
Vehicle: Subjects were 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 was not to be applied around the eyes or near the mucous membranes. No other acne treatments was applied to the face during study participation. | 33 |
| NAG (Next Science Acne Gel) Subjects were treated with once daily vehicle and attended screening, randomization, 2,4,8 and 12 week visits. The following was assessed:
1. Lesions were counted and right, left and forward facing photographs were taken
2. Investigator Global Assessment
3. Acne Quality of Life Questionnaire
4. Treatment Area Assessment by Investigator
Next Science Acne Gel: Subjects were 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 was not to be applied around the eyes or near the mucous membranes. No other acne treatments was applied to the face during study participation. | 35 |
| Total | 68 |
Baseline characteristics
| Characteristic | Vehicle | NAG (Next Science Acne Gel) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 35 Participants | 68 Participants |
| Region of Enrollment United States | 33 Participants | 35 Participants | 68 Participants |
| Sex: Female, Male Female | 19 Participants | 21 Participants | 40 Participants |
| Sex: Female, Male Male | 14 Participants | 14 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 35 |
| other Total, other adverse events | 7 / 33 | 9 / 35 |
| serious Total, serious adverse events | 0 / 33 | 0 / 35 |
Outcome results
Primary
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.
Time frame: Baseline until 12 weeks
Population: Subjects who completes all visits.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use. | -27 % change of inflammatory lesions count | Standard Error 12.5 |
| NAG (Next Science Acne Gel) | Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use. | -44 % change of inflammatory lesions count | Standard Error 8.6 |
p-value: <0.01ANOVA
Secondary
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).
Time frame: Baseline until 12 weeks
Population: NAG application resulted in average Burning or Stinging scores increasing from 0.0 to 0.1 over 12 weeks, compared to a decrease in Vehicle Control from 0.1 to 0.0.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Change in Burning/Stinging With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | .1 Average score on a scale | Standard Deviation 0.3 |
| Vehicle | Change in Burning/Stinging With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean after 12 Weeks | 0 Average score on a scale | Standard Deviation 0.3 |
| NAG (Next Science Acne Gel) | Change in Burning/Stinging With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | 0 Average score on a scale | Standard Deviation 0 |
| NAG (Next Science Acne Gel) | Change in Burning/Stinging With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean after 12 Weeks | 0.1 Average score on a scale | Standard Deviation 0.3 |
Secondary
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).
Time frame: Baseline until 12 weeks
Population: NAG application yielded Dryness average scores decreasing from 0.3 to 0.1 over 12 weeks compared to no decrease in the Vehicle control (0.3 to 0.3).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Change in Dryness With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean after 12 Weeks | 0.3 Average score on a scale | Standard Deviation 0.5 |
| Vehicle | Change in Dryness With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | .3 Average score on a scale | Standard Deviation 0.5 |
| NAG (Next Science Acne Gel) | Change in Dryness With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean after 12 Weeks | 0.1 Average score on a scale | Standard Deviation 0.5 |
| NAG (Next Science Acne Gel) | Change in Dryness With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | .3 Average score on a scale | Standard Deviation 0.5 |
Secondary
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).
Time frame: Baseline until 12 weeks
Population: NAG application resulted in average scores decreasing from 0.1 to 0.0 for the Acne Gel, and from 0.2 to 0.1 for the Vehicle Control.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Change in Edema With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | .2 Average score on a scale | Standard Deviation 0.4 |
| Vehicle | Change in Edema With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean after 12 Weeks | 0.1 Average score on a scale | Standard Deviation 0.4 |
| NAG (Next Science Acne Gel) | Change in Edema With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | 0.1 Average score on a scale | Standard Deviation 0.3 |
| NAG (Next Science Acne Gel) | Change in Edema With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean after 12 Weeks | 0 Average score on a scale | Standard Deviation 0.3 |
Secondary
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).
Time frame: Baseline until 12 weeks
Population: NAG application resulted in average scores remaining between 0.1 and 0.0 for all time points for both NAG and Vehicle groups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Change in Erosion With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | 0 Average score on a scale | Standard Deviation 0 |
| Vehicle | Change in Erosion With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean after 12 Weeks | 0 Average score on a scale | Standard Deviation 0.1 |
| NAG (Next Science Acne Gel) | Change in Erosion With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | 0 Average score on a scale | Standard Deviation 0 |
| NAG (Next Science Acne Gel) | Change in Erosion With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean after 12 Weeks | 0 Average score on a scale | Standard Deviation 0.1 |
Secondary
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).
Time frame: Baseline until 12 weeks
Population: The Next Science Acne Gel had average erythema score decreasing from 0.5 to 0.3 for the Acne Gel and to 0.5 to 0.4 for the Vehicle Control (not shown).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Change in Erythema Scores With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | .5 Average Score on a scale | Standard Deviation 0.8 |
| Vehicle | Change in Erythema Scores With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean after 12 weeks | 0.4 Average Score on a scale | Standard Deviation 0.8 |
| NAG (Next Science Acne Gel) | Change in Erythema Scores With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | .5 Average Score on a scale | Standard Deviation 0.7 |
| NAG (Next Science Acne Gel) | Change in Erythema Scores With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean after 12 weeks | 0.3 Average Score on a scale | Standard Deviation 0.5 |
Secondary
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).
Time frame: Baseline until 12 weeks
Population: NAG application resulted in Itching scores of 0.1 to 0.0 for the Acne Gel and from 0.2 to 0.0 for the Vehicle Control.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Change in Itching With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | .2 Average score on a scale | Standard Deviation 0.5 |
| Vehicle | Change in Itching With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at 12 Weeks | 0 Average score on a scale | Standard Deviation 0.3 |
| NAG (Next Science Acne Gel) | Change in Itching With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | .1 Average score on a scale | Standard Deviation 0.3 |
| NAG (Next Science Acne Gel) | Change in Itching With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at 12 Weeks | 0 Average score on a scale | Standard Deviation 0.3 |
Secondary
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).
Time frame: Baseline until 12 weeks
Population: NAG and vehicle application yielded average pain scores decreasing from 0.1 to 0.0.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Change in Pain With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | .1 Average score on a scale | Standard Deviation 0.2 |
| Vehicle | Change in Pain With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at 12 Weeks | 0 Average score on a scale | Standard Deviation 0.3 |
| NAG (Next Science Acne Gel) | Change in Pain With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | .1 Average score on a scale | Standard Deviation 0.4 |
| NAG (Next Science Acne Gel) | Change in Pain With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at 12 Weeks | 0 Average score on a scale | Standard Deviation 0.3 |
Secondary
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).
Time frame: Baseline until 12 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Final Investigator Global Assessment Score With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | 2.8 Score on a scale | Standard Error 0.08 |
| Vehicle | Final Investigator Global Assessment Score With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean after 12 Weeks | 2.3 Score on a scale | Standard Error 0.13 |
| NAG (Next Science Acne Gel) | Final Investigator Global Assessment Score With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | 2.4 Score on a scale | Standard Error 0.09 |
| NAG (Next Science Acne Gel) | Final Investigator Global Assessment Score With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean after 12 Weeks | 2.0 Score on a scale | Standard Error 0.14 |
p-value: <0.001ANOVA
Secondary
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
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vehicle | Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment. | -6.5 % Change Non-inflammatory lesion count | Standard Deviation 7.1 |
| NAG (Next Science Acne Gel) | Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment. | -34.1 % Change Non-inflammatory lesion count | Standard Deviation 5.8 |
Other Pre-specified
Change in Quality of Life - Perceived Acne Symptoms With Daily Use of NAG Compared With Vehicle After 12-weeks.
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Change in Quality of Life - Perceived Acne Symptoms With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | 3.4 Score on a scale | Standard Deviation 1.1 |
| Vehicle | Change in Quality of Life - Perceived Acne Symptoms With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at 12 Weeks | 4.4 Score on a scale | Standard Deviation 1.3 |
| NAG (Next Science Acne Gel) | Change in Quality of Life - Perceived Acne Symptoms With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | 3.4 Score on a scale | Standard Deviation 1.2 |
| NAG (Next Science Acne Gel) | Change in Quality of Life - Perceived Acne Symptoms With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at 12 Weeks | 4.5 Score on a scale | Standard Deviation 1.1 |
Other Pre-specified
Change in Quality of Life - Role Emotional With Daily Use of NAG Compared With Vehicle After 12-weeks.
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Change in Quality of Life - Role Emotional With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | 3.9 Score on a scale | Standard Deviation 1.6 |
| Vehicle | Change in Quality of Life - Role Emotional With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at 12 Weeks | 4.6 Score on a scale | Standard Deviation 1.4 |
| NAG (Next Science Acne Gel) | Change in Quality of Life - Role Emotional With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | 3.9 Score on a scale | Standard Deviation 1.8 |
| NAG (Next Science Acne Gel) | Change in Quality of Life - Role Emotional With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at 12 Weeks | 4.8 Score on a scale | Standard Deviation 1.3 |
Other Pre-specified
Change in Quality of Life - Role Social With Daily Use of NAG Compared With Vehicle After 12-weeks.
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
Population: The average Role-Social score increased from 4.5 to 5.3.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Change in Quality of Life - Role Social With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | 4.1 Score on a scale | Standard Deviation 2 |
| Vehicle | Change in Quality of Life - Role Social With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at 12 Weeks | 4.7 Score on a scale | Standard Deviation 1.7 |
| NAG (Next Science Acne Gel) | Change in Quality of Life - Role Social With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | 4.5 Score on a scale | Standard Deviation 2 |
| NAG (Next Science Acne Gel) | Change in Quality of Life - Role Social With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at 12 Weeks | 5.3 Score on a scale | Standard Deviation 1.6 |
Other Pre-specified
Change in Quality of Life - Self Perception With Daily Use of NAG Compared With Vehicle After 12-weeks.
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
Population: The average self-perception score for NAG users increased from 4.1 to 5.0.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle | Change in Quality of Life - Self Perception With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | 3.5 Score on a scale | Standard Deviation 2.1 |
| Vehicle | Change in Quality of Life - Self Perception With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at 12 Weeks | 4.6 Score on a scale | Standard Deviation 1.5 |
| NAG (Next Science Acne Gel) | Change in Quality of Life - Self Perception With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at Baseline | 4.1 Score on a scale | Standard Deviation 1.9 |
| NAG (Next Science Acne Gel) | Change in Quality of Life - Self Perception With Daily Use of NAG Compared With Vehicle After 12-weeks. | Mean at 12 Weeks | 5.0 Score on a scale | Standard Deviation 1.5 |