Back to resultsSix Months Evaluation of Next Science Acne Creams on Facial Acne in Adult Females.
Primary Purpose
Acne Vulgaris
Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Acne cream 2X
Acne cream 1X
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Skin Laser & Surgery Specialists of NY & NJ
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Acne cream 1x
Acne cream 2x
Arm Description
Twice-daily facial applications of the 1X product (avoiding contact with eyes and all mucous membranes) to the entire face for 6 months.
Twice-daily facial applications of the 2X product (avoiding contact with eyes and all mucous membranes) to the entire face for 6 months.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Inflammatory Lesion count over time
to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 inflammatory lesion counts
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
Investigator Global Assessment over time
to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in IGA
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)
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.
Full Information
NCT ID
NCT03106766
First Posted
March 27, 2017
Last Updated
August 28, 2017
Sponsor
Next Science TM
Collaborators
Skin Laser & Surgery Specialists
1. Study Identification
Unique Protocol Identification Number
NCT03106766
Brief Title
Six Months Evaluation of Next Science Acne Creams on Facial Acne in Adult Females.
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.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
Decision from the Sponsor
Study Start Date
March 27, 2017 (Actual)
Primary Completion Date
August 14, 2017 (Actual)
Study Completion Date
August 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Next Science TM
Collaborators
Skin Laser & Surgery Specialists
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acne cream 1x
Arm Type
Experimental
Arm Description
Twice-daily facial applications of the 1X product (avoiding contact with eyes and all mucous membranes) to the entire face for 6 months.
Arm Title
Acne cream 2x
Arm Type
Experimental
Arm Description
Twice-daily facial applications of the 2X product (avoiding contact with eyes and all mucous membranes) to the entire face for 6 months.
Intervention Type
Drug
Intervention Name(s)
Acne cream 2X
Intervention Description
Twice daily application of facial acne cream 2X after facial cleansing
Intervention Type
Drug
Intervention Name(s)
Acne cream 1X
Intervention Description
Twice daily application of facial acne cream 1X after facial cleansing
Primary Outcome Measure Information:
Title
Reduction in Lesion Count
Description
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.
Time Frame
Baseline versus 6 months
Secondary Outcome Measure Information:
Title
Inflammatory Lesion count over time
Description
to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 inflammatory lesion counts
Time Frame
weeks 6, 12, 18, and 24
Title
Non-inflammatory acne lesion over time
Description
to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in non-inflammatory lesion counts
Time Frame
weeks 6, 12, 18, and 24
Title
Investigator Global Assessment over time
Description
to assess the mean percent change from baseline to weeks 6, 12, 18, and 24 in IGA
Time Frame
weeks 6, 12, 18, and 24
Title
Treatment Areas over time
Description
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)
Time Frame
weeks 6, 12, 18, and 24
Title
Quality of Life over time
Description
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.
Time Frame
weeks 6, 12, 18, and 24
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matt Myntti, PhD
Organizational Affiliation
Next Science
Official's Role
Study Director
Facility Information:
Facility Name
Skin Laser & Surgery Specialists of NY & NJ
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Six Months Evaluation of Next Science Acne Creams on Facial Acne in Adult Females.
We'll reach out to this number within 24 hrs