Trial Outcomes & Findings for A Study to Evaluate the Clinical Effect of Daily Next Science™ Acne Gel (NAG) on Mild to Moderate Facial Acne (NCT NCT02404285)

Results Overview

Percent change in number of Inflammatory lesions with daily use of NAG compared with vehicle after 12-weeks of use.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

68 participants

Primary outcome timeframe

Baseline until 12 weeks

Results posted on

2023-11-08

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Vehicle 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: 1. Lesions will be counted and right, left and forward facing photographs will be taken 2. Investigator Global Assessment 3. Acne Quality of Life Questionnaire 4. Treatment Area Assessment by Investigator Vehicle: 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.	NAG (Next Science Acne Gel) 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: 1. Lesions will be counted and right, left and forward facing photographs will be taken 2. Investigator Global Assessment 3. Acne Quality of Life Questionnaire 4. Treatment Area Assessment by Investigator Next 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.
Overall Study STARTED	33	35
Overall Study COMPLETED	31	33
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Evaluate the Clinical Effect of Daily Next Science™ Acne Gel (NAG) on Mild to Moderate Facial Acne

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vehicle n=33 Participants 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.	NAG (Next Science Acne Gel) n=35 Participants 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.	Total n=68 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	33 Participants n=5 Participants	35 Participants n=7 Participants	68 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	33 Participants n=5 Participants	35 Participants n=7 Participants	68 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline until 12 weeks

Population: Subjects who completes all visits.

Percent change in number of Inflammatory lesions with daily use of NAG compared with vehicle after 12-weeks of use.

Outcome measures

Outcome measures
Measure	Vehicle n=33 Participants Subjects were treated with once daily vehicle and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken	NAG (Next Science Acne Gel) n=35 Participants Subjects were treated with once daily NAG and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken
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	-44 % change of inflammatory lesions count Standard Error 8.6

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vehicle n=33 Participants Subjects were treated with once daily vehicle and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken	NAG (Next Science Acne Gel) n=35 Participants Subjects were treated with once daily NAG and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken
Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment.	-6.5 % Change Non-inflammatory lesion count Standard Deviation 7.1	-34.1 % Change Non-inflammatory lesion count Standard Deviation 5.8

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Vehicle n=33 Participants Subjects were treated with once daily vehicle and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken	NAG (Next Science Acne Gel) n=35 Participants Subjects were treated with once daily NAG and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken
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 .08	2.4 Score on a scale Standard Error .09
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	2.0 Score on a scale Standard Error 0.14

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

Outcome measures
Measure	Vehicle n=33 Participants Subjects were treated with once daily vehicle and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken	NAG (Next Science Acne Gel) n=35 Participants Subjects were treated with once daily NAG and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken
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 .8	.5 Average Score on a scale Standard Deviation .7
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	0.3 Average Score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 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).

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).

Outcome measures

Outcome measures
Measure	Vehicle n=33 Participants Subjects were treated with once daily vehicle and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken	NAG (Next Science Acne Gel) n=35 Participants Subjects were treated with once daily NAG and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken
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 .5	.3 Average score on a scale Standard Deviation .5
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	0.1 Average score on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Vehicle n=33 Participants Subjects were treated with once daily vehicle and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken	NAG (Next Science Acne Gel) n=35 Participants Subjects were treated with once daily NAG and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken
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 .3	0 Average score on a scale Standard Deviation 0
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	0.1 Average score on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Vehicle n=33 Participants Subjects were treated with once daily vehicle and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken	NAG (Next Science Acne Gel) n=35 Participants Subjects were treated with once daily NAG and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken
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	0 Average score on a scale Standard Deviation 0
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	0 Average score on a scale Standard Deviation 0.1

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Vehicle n=33 Participants Subjects were treated with once daily vehicle and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken	NAG (Next Science Acne Gel) n=35 Participants Subjects were treated with once daily NAG and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken
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 .4	0.1 Average score on a scale Standard Deviation .3
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	0 Average score on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: Baseline until 12 weeks

Population: NAG and vehicle application yielded average pain scores decreasing from 0.1 to 0.0.

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).

Outcome measures

Outcome measures
Measure	Vehicle n=33 Participants Subjects were treated with once daily vehicle and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken	NAG (Next Science Acne Gel) n=35 Participants Subjects were treated with once daily NAG and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken
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 .2	.1 Average score on a scale Standard Deviation .4
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	0 Average score on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Vehicle n=33 Participants Subjects were treated with once daily vehicle and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken	NAG (Next Science Acne Gel) n=35 Participants Subjects were treated with once daily NAG and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken
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 .5	.1 Average score on a scale Standard Deviation .3
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	0 Average score on a scale Standard Deviation 0.3

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline until 12 weeks

Population: The average self-perception score for NAG users increased from 4.1 to 5.0.

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.

Outcome measures

Outcome measures
Measure	Vehicle n=33 Participants Subjects were treated with once daily vehicle and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken	NAG (Next Science Acne Gel) n=35 Participants Subjects were treated with once daily NAG and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken
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	4.1 Score on a scale Standard Deviation 1.9
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	5.0 Score on a scale Standard Deviation 1.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vehicle n=33 Participants Subjects were treated with once daily vehicle and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken	NAG (Next Science Acne Gel) n=35 Participants Subjects were treated with once daily NAG and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken
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	3.9 Score on a scale Standard Deviation 1.8
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	4.8 Score on a scale Standard Deviation 1.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Vehicle n=33 Participants Subjects were treated with once daily vehicle and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken	NAG (Next Science Acne Gel) n=35 Participants Subjects were treated with once daily NAG and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken
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	3.4 Score on a scale Standard Deviation 1.2
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	4.5 Score on a scale Standard Deviation 1.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline until 12 weeks

Population: The average Role-Social score increased from 4.5 to 5.3.

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

Outcome measures

Outcome measures
Measure	Vehicle n=33 Participants Subjects were treated with once daily vehicle and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken	NAG (Next Science Acne Gel) n=35 Participants Subjects were treated with once daily NAG and the following was assessed at baseline, 2,4,8 and 12 week visits: 1\. Lesions were counted and right, left and forward facing photographs were taken
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 2.0	4.5 Score on a scale Standard Deviation 2.0
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	5.3 Score on a scale Standard Deviation 1.6

Adverse Events

Vehicle

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

NAG (Next Science Acne Gel)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Vehicle n=33 participants at risk 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.	NAG (Next Science Acne Gel) n=35 participants at risk Subjects were treated with once daily NAG 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.
Infections and infestations Bronchitis	3.0% 1/33 • Number of events 1 • 12 Weeks.	0.00% 0/35 • 12 Weeks.
General disorders Gastritis	3.0% 1/33 • Number of events 1 • 12 Weeks.	0.00% 0/35 • 12 Weeks.
General disorders Vomiting	3.0% 1/33 • Number of events 1 • 12 Weeks.	0.00% 0/35 • 12 Weeks.
Infections and infestations Haemtoma	3.0% 1/33 • Number of events 1 • 12 Weeks.	0.00% 0/35 • 12 Weeks.
Infections and infestations Rhinitis	6.1% 2/33 • Number of events 2 • 12 Weeks.	0.00% 0/35 • 12 Weeks.
Infections and infestations Urinary Tract Infection	0.00% 0/33 • 12 Weeks.	2.9% 1/35 • Number of events 1 • 12 Weeks.
General disorders Headache	0.00% 0/33 • 12 Weeks.	2.9% 1/35 • Number of events 1 • 12 Weeks.
General disorders General aches	0.00% 0/33 • 12 Weeks.	2.9% 1/35 • Number of events 1 • 12 Weeks.
General disorders Mild celiac disease	0.00% 0/33 • 12 Weeks.	2.9% 1/35 • Number of events 1 • 12 Weeks.
General disorders Abdominal cramps	0.00% 0/33 • 12 Weeks.	2.9% 1/35 • Number of events 1 • 12 Weeks.
Infections and infestations Laryngitis	0.00% 0/33 • 12 Weeks.	2.9% 1/35 • Number of events 1 • 12 Weeks.
Infections and infestations Cough	0.00% 0/33 • 12 Weeks.	2.9% 1/35 • Number of events 1 • 12 Weeks.
Infections and infestations Upper Respiratory Infection	0.00% 0/33 • 12 Weeks.	2.9% 1/35 • Number of events 1 • 12 Weeks.
Infections and infestations Otitis Media	0.00% 0/33 • 12 Weeks.	2.9% 1/35 • Number of events 1 • 12 Weeks.
General disorders Fatigue	3.0% 1/33 • Number of events 1 • 12 Weeks.	0.00% 0/35 • 12 Weeks.

Additional Information

Matt Myntti PHD, President

Next Science

Phone: 9046474161

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place