A Phase 1/2 interventional study of Next Science Acne Gel and Vehicle in Acne Vulgaris, sponsored by Next Science TM. Completed at 3 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-11-08.
Sponsored by Next Science TM · Phase 1/2, Interventional, and Treatment
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.
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:
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.
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's enrollment of 68 is close to the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Next Science TM is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Vehicle
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
Drug: 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.
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.
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
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
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
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
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
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
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
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
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
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
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
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
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
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
| Milestone | Vehicle | NAG (Next Science Acne Gel) |
|---|---|---|
| Started | 33 | 35 |
| Completed | 31 | 33 |
| Not completed | 2 | 2 |
Percent change in number of Inflammatory lesions with daily use of NAG compared with vehicle after 12-weeks of use.
| % change of inflammatory lesions count | Vehicle | NAG (Next Science Acne Gel) |
|---|---|---|
| Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use. | -27 ± 12.5 | -44 ± 8.6 |
Percent Change in Number of Non-inflammatory lesions (open and closed comedones) were counted after 12 weeks of either Vehicle of NAG treatment
| % Change Non-inflammatory lesion count | Vehicle | NAG (Next Science Acne Gel) |
|---|---|---|
| Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment. | -6.5 ± 7.1 | -34.1 ± 5.8 |
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).
| Score on a scale | Vehicle | NAG (Next Science Acne Gel) |
|---|---|---|
| Mean at Baseline | 2.8 ± .08 | 2.4 ± .09 |
| Mean after 12 Weeks | 2.3 ± 0.13 | 2.0 ± 0.14 |
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).
| Average Score on a scale | Vehicle | NAG (Next Science Acne Gel) |
|---|---|---|
| Mean at Baseline | .5 ± .8 | .5 ± .7 |
| Mean after 12 weeks | 0.4 ± 0.8 | 0.3 ± 0.5 |
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).
| Average score on a scale | Vehicle | NAG (Next Science Acne Gel) |
|---|---|---|
| Mean at Baseline | .3 ± .5 | .3 ± .5 |
| Mean after 12 Weeks | 0.3 ± 0.5 | 0.1 ± 0.5 |
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).
| Average score on a scale | Vehicle | NAG (Next Science Acne Gel) |
|---|---|---|
| Mean at Baseline | .1 ± .3 | 0 ± 0 |
| Mean after 12 Weeks | 0 ± 0.3 | 0.1 ± 0.3 |
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).
| Average score on a scale | Vehicle | NAG (Next Science Acne Gel) |
|---|---|---|
| Mean at Baseline | 0 ± 0 | 0 ± 0 |
| Mean after 12 Weeks | 0 ± 0.1 | 0 ± 0.1 |
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).
| Average score on a scale | Vehicle | NAG (Next Science Acne Gel) |
|---|---|---|
| Mean at Baseline | .2 ± .4 | 0.1 ± .3 |
| Mean after 12 Weeks | 0.1 ± 0.4 | 0 ± 0.3 |
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).
| Average score on a scale | Vehicle | NAG (Next Science Acne Gel) |
|---|---|---|
| Mean at Baseline | .1 ± .2 | .1 ± .4 |
| Mean at 12 Weeks | 0 ± 0.3 | 0 ± 0.3 |
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).
| Average score on a scale | Vehicle | NAG (Next Science Acne Gel) |
|---|---|---|
| Mean at Baseline | .2 ± .5 | .1 ± .3 |
| Mean at 12 Weeks | 0 ± 0.3 | 0 ± 0.3 |
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.
| Score on a scale | Vehicle | NAG (Next Science Acne Gel) |
|---|---|---|
| Mean at Baseline | 3.5 ± 2.1 | 4.1 ± 1.9 |
| Mean at 12 Weeks | 4.6 ± 1.5 | 5.0 ± 1.5 |
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
| Score on a scale | Vehicle | NAG (Next Science Acne Gel) |
|---|---|---|
| Mean at Baseline | 3.9 ± 1.6 | 3.9 ± 1.8 |
| Mean at 12 Weeks | 4.6 ± 1.4 | 4.8 ± 1.3 |
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
| Score on a scale | Vehicle | NAG (Next Science Acne Gel) |
|---|---|---|
| Mean at Baseline | 3.4 ± 1.1 | 3.4 ± 1.2 |
| Mean at 12 Weeks | 4.4 ± 1.3 | 4.5 ± 1.1 |
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
| Score on a scale | Vehicle | NAG (Next Science Acne Gel) |
|---|---|---|
| Mean at Baseline | 4.1 ± 2.0 | 4.5 ± 2.0 |
| Mean at 12 Weeks | 4.7 ± 1.7 | 5.3 ± 1.6 |
Collected over 12 Weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vehicle | 0/33 (0%) | 0/33 (0%) | 7/33 (21.2%) |
| NAG (Next Science Acne Gel) | 0/35 (0%) | 0/35 (0%) | 9/35 (25.7%) |
| Event | Vehicle | NAG (Next Science Acne Gel) |
|---|---|---|
| RhinitisInfections and infestations | 2/33 | 0/35 |
| BronchitisInfections and infestations | 1/33 | 0/35 |
| GastritisGeneral disorders | 1/33 | 0/35 |
| VomitingGeneral disorders | 1/33 | 0/35 |
| HaemtomaInfections and infestations | 1/33 | 0/35 |
| FatigueGeneral disorders | 1/33 | 0/35 |
| Urinary Tract InfectionInfections and infestations | 0/33 | 1/35 |
| HeadacheGeneral disorders | 0/33 | 1/35 |
| General achesGeneral disorders | 0/33 | 1/35 |
| Mild celiac diseaseGeneral disorders | 0/33 | 1/35 |
| Age, Categorical(Participants) | Vehicle | NAG (Next Science Acne Gel) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 33 | 35 | 68 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Vehicle | NAG (Next Science Acne Gel) | Total |
|---|---|---|---|
| Female | 19 | 21 | 40 |
| Male | 14 | 14 | 28 |
| Region of Enrollment(Participants) | Vehicle | NAG (Next Science Acne Gel) | Total |
|---|---|---|---|
| United States | 33 | 35 | 68 |
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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