Acne VulgarisPhase 1/2NCT02404285
A Study to Evaluate the Clinical Effect of Daily Next Science™ Acne Gel (NAG) on Mild to Moderate Facial Acne
A Phase 1/2 study testing Next Science Acne Gel in people with Acne Vulgaris, run by Next Science TM at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Next Science Acne Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2015to Sep 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Fleming Island Center for Clinical Research
Jacksonville, Florida, 32203
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
St. Johns Center for Clinical Research
Ponte Vedra, Florida, 32081
About this study
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
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.
Read the 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.
- Conditions
- Acne Vulgaris
- Being tested
- Next Science Acne Gel, Vehicle
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next Science Acne GelDrug
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.
VehicleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Vehicle | Placebo comparator | 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 Receives: Drug: Vehicle |
| NAG (Next Science Acne Gel) | Active comparator | 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 Receives: Drug: Next Science Acne Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline until 12 weeks
Secondary outcomes (9)
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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Baseline until 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Next Science TM
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jacksonville Center For Clinical Research, St. Johns Center for Clinical Research, Fleming Island Center for Clinical Research
- Responsible party
- Sponsor
- Investigators
- Susan Greco, MD, Study director, Jacksonville Center For Clinical ResearchAnnabelle Matias, MD, Principal investigator, Fleming Island Center for Clinical ResearchLara Church, MD, Principal investigator, St John's Center for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404285
- Sponsor's protocol ID
- CSP-003
- Status last verified
- Nov 2023
- First submitted
- 13 Mar 2015
- Last updated
- 8 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 27272073
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02404285
- Acronym / sponsor ID
- CSP-003
- Conditions
- Acne Vulgaris
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Next Science TMIndustry (pharma, biotech, devices)
- Collaborators
- Jacksonville Center For Clinical Research, St. Johns Center for Clinical Research, Fleming Island Center for Clinical Research
- Study start
- Mar 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Posted 29 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vehicle | Placebo comparator | Drug: VehicleSubjects 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 |
| NAG (Next Science Acne Gel) | Active comparator | Drug: Next Science Acne GelSubjects 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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Next Science Acne GelSubjects 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. | Drug | NAG (Next Science Acne Gel) |
| VehicleSubjects 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. | Drug | Vehicle |
Primary outcome
Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use.
Time frame: Baseline until 12 weeks
Percent change in number of Inflammatory lesions with daily use of NAG compared with vehicle after 12-weeks of use.
9 secondary outcomes
Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment.
Time frame: 12 weeks
Final Investigator Global Assessment Score With Daily Use of NAG Compared With Vehicle After 12-weeks.
Time frame: Baseline until 12 weeks
Change in Erythema Scores With Daily Use of NAG Compared With Vehicle After 12-weeks.
Time frame: Baseline until 12 weeks
Change in Dryness With Daily Use of NAG Compared With Vehicle After 12-weeks.
Time frame: Baseline until 12 weeks
Change in Burning/Stinging With Daily Use of NAG Compared With Vehicle After 12-weeks.
Time frame: Baseline until 12 weeks
Change in Erosion With Daily Use of NAG Compared With Vehicle After 12-weeks.
Time frame: Baseline until 12 weeks
Change in Edema With Daily Use of NAG Compared With Vehicle After 12-weeks.
Time frame: Baseline until 12 weeks
Change in Pain With Daily Use of NAG Compared With Vehicle After 12-weeks.
Time frame: Baseline until 12 weeks
Change in Itching With Daily Use of NAG Compared With Vehicle After 12-weeks.
Time frame: Baseline until 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27272073Bernhardt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Greco, MD study director
Jacksonville Center For Clinical Research
Annabelle Matias, MD principal investigator
Fleming Island Center for Clinical Research
Lara Church, MD principal investigator
St John's Center for Clinical Research
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Next Science Acne Gel in people with Acne Vulgaris, run by Next Science TM at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use. (time frame: Baseline until 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02404285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.