Acne VulgarisEarly Phase 1NCT03106766
Six Months Evaluation of Next Science Acne Creams on Facial Acne in Adult Females.
A Early Phase 1 study testing Acne cream 2X and Acne cream 1X in people with Acne Vulgaris, run by Next Science TM at 1 site in United States.
Trial summary
To assess facial acne vulgaris clinical and psychological outcomes by measuring differences in lesions counts, investigator global assessment, and subjects quality of life scores over 6 months in adult females treated with Next Science™ acne cream 2x or Next Science™ acne cream 1x in a double blind manner. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Acne cream 2X and Acne cream 1X
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Mar 2017to 14 Aug 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female ages 18 and above
- Has 20 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.
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 used any systemic medications (including antibiotics, estrogens, retinoids) primarily for treatment of acne in the 21 days prior to randomization.
- Has used estrogens primarily as treatment for acne in the 21 days prior to randomization (estrogens prescribed for other reasons will be allowed if stable for at least 30 days prior to randomization).
- Has had any professional facial treatments in the 14 days prior to randomization.
- Has received any investigational treatment in the 30 days prior to randomization.
- Have any significant medical problems or other issues that would, in the investigator's judgment, affect their suitability for participation in this trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Skin Laser & Surgery Specialists of NY & NJ
Hackensack, New Jersey, 07601
About this study
Official title: A Single-center, Double-blind, Controlled Study to Evaluate the Effect of Next Science™ Acne Cream on Mild to Moderate Facial Acne in Adult Females Over 6 Months.
To assess facial acne vulgaris clinical and psychological outcomes by measuring differences in lesions counts, investigator global assessment, and subjects quality of life scores over 6 months in adult females treated with Next Science™ acne cream 2x or Next Science™ acne cream 1x in a double blind manner.
Read the detailed description
This is a 6-month, single-site, double-blind, controlled study in 20 female subjects with mild to moderate facial acne. Subjects will be randomized 1:1 to apply either topical Next Science™ acne cream 2x or Next Science™ acne cream 1x daily. Subjects will be evaluated for clinical acne and quality of life outcomes at baseline, 6, 12, 18 and 24 weeks.
- Conditions
- Acne Vulgaris
- Being tested
- Acne cream 2X, Acne cream 1X
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acne cream 2XDrug
Twice daily application of facial acne cream 2X after facial cleansing
Acne cream 1XDrug
Twice daily application of facial acne cream 1X after facial cleansing
| Study group | Role | What they receive |
|---|---|---|
| Acne cream 1x | Experimental | Twice-daily facial applications of the 1X product (avoiding contact with eyes and all mucous membranes) to the entire face for 6 months. Receives: Drug: Acne cream 1X |
| Acne cream 2x | Experimental | Twice-daily facial applications of the 2X product (avoiding contact with eyes and all mucous membranes) to the entire face for 6 months. Receives: Drug: Acne cream 2X |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Lesion Count
Inflammatory acne lesions with both study acne cream products after 6 months of treatment compared to baseline. This will be measured as the mean percent change from baseline to week 24 in the inflammatory lesion count.
Measured: Baseline versus 6 months
Secondary outcomes (5)
Inflammatory Lesion count over time
to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 inflammatory lesion counts
Measured: weeks 6, 12, 18, and 24
Non-inflammatory acne lesion over time
to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in non-inflammatory lesion counts
Measured: weeks 6, 12, 18, and 24
Investigator Global Assessment over time
to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in IGA
Measured: weeks 6, 12, 18, and 24
Treatment Areas over time
to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in treatment areas (erythema, dryness, stinging or burning, erosion, edema, pain and itching)
Measured: weeks 6, 12, 18, and 24
Quality of Life over time
The Acne-QoL questionnaire containing 19 questions organized into four domains which address the impact of facial acne on health-related quality of life will be administered. These are Self Perception, Role-social, Role-emotional and Acne Symptoms. Results will assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in QoL.
Measured: weeks 6, 12, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2017
- Study start27 Mar 2017
- Primary completion14 Aug 2017
- Study completion14 Aug 2017
Why it stopped: Decision from the Sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Next Science TM
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Skin Laser & Surgery Specialists
- Responsible party
- Sponsor
- Investigators
- Matt Myntti, PhD, Study director, Next Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03106766
- Sponsor's protocol ID
- CSP-004
- Status last verified
- Aug 2017
- First submitted
- 27 Mar 2017
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marshall-Hudson A, Tuley M, Damstra M, Dosik JS, Myntti MF, Porral D, Palomo J. A 6-month, Multi-center, Double-blind, Controlled Study to Evaluate the Effect of a Biofilm Disrupting Acne Cream on Mild-to-Moderate Facial Acne in Female Volunteer Subjects. J Clin Aesthet Dermatol. 2023 Apr;16(4):43-52.
PubMed 37077927
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Double-blind, Controlled Study to Evaluate the Effect of Next Science™ Acne Cream on Mild to Moderate Facial Acne in Adult Females Over 6 Months.
- ClinicalTrials.gov ID
- NCT03106766
- Acronym / sponsor ID
- CSP-004
- Conditions
- Acne Vulgaris
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision from the Sponsor
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Next Science TMIndustry (pharma, biotech, devices)
- Collaborators
- Skin Laser & Surgery Specialists
- Study start
- 27 Mar 2017 (actual)
- Primary completion
- 14 Aug 2017 (actual)
- Study completion
- 14 Aug 2017 (actual)
- First posted
- 10 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess facial acne vulgaris clinical and psychological outcomes by measuring differences in lesions counts, investigator global assessment, and subjects quality of life scores over 6 months in adult females treated with Next Science™ acne cream 2x or Next Science™ acne cream 1x in a double blind manner.
Detailed description
This is a 6-month, single-site, double-blind, controlled study in 20 female subjects with mild to moderate facial acne. Subjects will be randomized 1:1 to apply either topical Next Science™ acne cream 2x or Next Science™ acne cream 1x daily. Subjects will be evaluated for clinical acne and quality of life outcomes at baseline, 6, 12, 18 and 24 weeks.
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 |
|---|---|---|
| Acne cream 1x | Experimental | Drug: Acne cream 1XTwice-daily facial applications of the 1X product (avoiding contact with eyes and all mucous membranes) to the entire face for 6 months. |
| Acne cream 2x | Experimental | Drug: Acne cream 2XTwice-daily facial applications of the 2X product (avoiding contact with eyes and all mucous membranes) to the entire face for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female ages 18 and above
- Has 20 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 (8 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 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).
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 |
|---|---|---|
| Acne cream 2XTwice daily application of facial acne cream 2X after facial cleansing | Drug | Acne cream 2x |
| Acne cream 1XTwice daily application of facial acne cream 1X after facial cleansing | Drug | Acne cream 1x |
Primary outcome
Reduction in Lesion Count
Time frame: Baseline versus 6 months
Inflammatory acne lesions with both study acne cream products after 6 months of treatment compared to baseline. This will be measured as the mean percent change from baseline to week 24 in the inflammatory lesion count.
5 secondary outcomes
Inflammatory Lesion count over time
Time frame: weeks 6, 12, 18, and 24
Non-inflammatory acne lesion over time
Time frame: weeks 6, 12, 18, and 24
Investigator Global Assessment over time
Time frame: weeks 6, 12, 18, and 24
Treatment Areas over time
Time frame: weeks 6, 12, 18, and 24
Quality of Life over time
Time frame: weeks 6, 12, 18, and 24
Results and safety
The study was stopped early (reason given: Decision from the Sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Derived from this study: PubMed 37077927Marshall-Hudson A, Tuley M, Damstra M, Dosik JS, Myntti MF, Porral D, Palomo J. A 6-month, Multi-center, Double-blind, Controlled Study to Evaluate the Effect of a Biofilm Disrupting Acne Cream on Mild-to-Moderate Facial Acne in Female Volunteer Subjects. J Clin Aesthet Dermatol. 2023 Apr;16(4):43-52.
- Individual participant dataSharing planned: No
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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.
Matt Myntti, PhD study director
Next Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Acne cream 2X and Acne cream 1X in people with Acne Vulgaris, run by Next Science TM at 1 site 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 8 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: stopped early, as of the sponsor's last update on 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Decision from the Sponsor). Results are not available in the source record.
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?
Reduction in Lesion Count (time frame: Baseline versus 6 months). 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 NCT03106766, 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 30 Aug 2017.