Back to resultsThe Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
Primary Purpose
Acne Vulgaris, Post Inflammatory Hyperpigmentation
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ONEXTON Topical Gel
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris
Eligibility Criteria
Inclusion Criteria:
i. Outpatient, subjects of skin of color, age 12 or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study;
A female is considered of childbearing potential unless she is:
- postmenopausal for at least 12 months prior to study drug administration
- without a uterus and/or both ovaries; or
- has been surgically sterile for at least 6 months prior to study drug administration
Reliable methods of contraception are:
- intrauterine device in use ≥ 90 days prior to study drug administration;
- barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
- vasectomized partner
[Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.]
ii. Facial acne vulgaris in patients with skin of color (Fitzpatrick Type V & VI Supplement VI) characterized by the following:
- IGA Score for acne vulgaris 3
- IGA Score for PIH 3
iii. Able to understand and comply with the requirements of the study and sign Informed Consent /HIPAA Authorization forms
Exclusion Criteria:
i. Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
ii. Allergy/sensitivity to any component of the test treatment
iii. IGA score for acne of 2 (mild) or 4 (severe)
iv. IGA score for Post Inflammatory Hyperpigmentation of 2 (mild) or 4 (severe)
v. Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I).
vi. Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study
vii. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris
viii. Evidence of recent alcohol or drug abuse
ix. History of poor cooperation, non-compliance with medical treatment, or unreliability
x. Exposure to an investigational study drug within 30 days of the Baseline Visit
Sites / Locations
- DermResearch, PLLC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm Onexton gel application
Arm Description
Onexton gel will be supplied to all subjects and applied once daily to the face
Outcomes
Primary Outcome Measures
Investigator Global Assessment Scale for Severity of Facial Acne
Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for facial acne; the IGA scale for acne reflects the Investigator's assessment of the severity of a subject's acne on a scale from 0 to 5 with 0 = Clear Skin, 1 = Almost Clear, 2 = Mild, 3 = Moderate severity, 4 = Severe, 5 = Very Severe Each of these gradations is based upon a lesion count by the Investigator.
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for severity of post inflammatory hyperpigmentation; the IGA scale of post-inflammatory hyperpigmentation reflects the Investigator's assessment of the severity of a subject's hyperpigmentation on a scale from 0 to 6 with 0 = None, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = moderately Severe, 5 = Severe, 6 = Very severe Each of these gradations is based upon the investigator's impression
Secondary Outcome Measures
Percent Change in Inflammatory Lesions
The Investigator will count the number of facial (from hairline to mandibular line) inflammatory acne lesions at each study visit. Inflammatory lesions include papules, pustules and nodules.
Percent Change in Non-inflammatory Lesion Count
The Investigator will count the number of facial non-inflammatory acne lesions at each study visit. these include open and closed comedones.
Percent Change in Total Lesion Count
The Investigator will count the number of facial inflammatory and non-inflammatory acne lesions at each study visit. These include papules, pustules, nodules, and open and closed comedones.
Post-Inflammatory Hyperpigmentation (PIH) Distribution
This measure as assessed by the Investigator seeks to quantify the extent to which post-inflammatory hyperpigmentation is distributed across the face, wherein 0= No PIH, 1=1-10% of the face affected, 2=11-20%, 3=21-30%, 4=31-40%, 5=41-50%, and 6=More than 50% of the face. Lower numbers reflect less severe disease.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03402893
Brief Title
The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
Official Title
The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
July 28, 2017 (Actual)
Primary Completion Date
November 15, 2017 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Derm Research, PLLC
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
5. Study Description
Brief Summary
This is a single-center, open label pilot study. The study is comprised of 5 study visits; Screening, Baseline, and Weeks 4, 8, and 16. All subjects will receive Onexton at Baseline and be instructed to apply the gel once daily to the face. The investigators will evaluate Investigator Global Assessment of acne (IGA), total lesion count, inflammatory lesion count, non-inflammatory lesion count, Investigator Global Assessment of Post-Inflammatory Hyperpigmentation and distribution of Post-Inflammatory Hyperpigmentation, adverse events and concomitant medications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris, Post Inflammatory Hyperpigmentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single arm Onexton gel application
Arm Type
Experimental
Arm Description
Onexton gel will be supplied to all subjects and applied once daily to the face
Intervention Type
Drug
Intervention Name(s)
ONEXTON Topical Gel
Intervention Description
Onexton gel applied once daily to face
Primary Outcome Measure Information:
Title
Investigator Global Assessment Scale for Severity of Facial Acne
Description
Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for facial acne; the IGA scale for acne reflects the Investigator's assessment of the severity of a subject's acne on a scale from 0 to 5 with 0 = Clear Skin, 1 = Almost Clear, 2 = Mild, 3 = Moderate severity, 4 = Severe, 5 = Very Severe Each of these gradations is based upon a lesion count by the Investigator.
Time Frame
Week 4, Week 8, Week 16
Title
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
Description
Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for severity of post inflammatory hyperpigmentation; the IGA scale of post-inflammatory hyperpigmentation reflects the Investigator's assessment of the severity of a subject's hyperpigmentation on a scale from 0 to 6 with 0 = None, 1 = Slight, 2 = Mild, 3 = Moderate, 4 = moderately Severe, 5 = Severe, 6 = Very severe Each of these gradations is based upon the investigator's impression
Time Frame
Week 4, Week 8, Week 16
Secondary Outcome Measure Information:
Title
Percent Change in Inflammatory Lesions
Description
The Investigator will count the number of facial (from hairline to mandibular line) inflammatory acne lesions at each study visit. Inflammatory lesions include papules, pustules and nodules.
Time Frame
Week 4, Week 8, Week 16
Title
Percent Change in Non-inflammatory Lesion Count
Description
The Investigator will count the number of facial non-inflammatory acne lesions at each study visit. these include open and closed comedones.
Time Frame
Week 4, Week 8, Week 16
Title
Percent Change in Total Lesion Count
Description
The Investigator will count the number of facial inflammatory and non-inflammatory acne lesions at each study visit. These include papules, pustules, nodules, and open and closed comedones.
Time Frame
week 4, Week 8, Week 16
Title
Post-Inflammatory Hyperpigmentation (PIH) Distribution
Description
This measure as assessed by the Investigator seeks to quantify the extent to which post-inflammatory hyperpigmentation is distributed across the face, wherein 0= No PIH, 1=1-10% of the face affected, 2=11-20%, 3=21-30%, 4=31-40%, 5=41-50%, and 6=More than 50% of the face. Lower numbers reflect less severe disease.
Time Frame
baseline, Week 4, week 8, week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
i. Outpatient, subjects of skin of color, age 12 or older. Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline and practice a reliable method of contraception throughout the study;
A female is considered of childbearing potential unless she is:
postmenopausal for at least 12 months prior to study drug administration
without a uterus and/or both ovaries; or
has been surgically sterile for at least 6 months prior to study drug administration
Reliable methods of contraception are:
intrauterine device in use ≥ 90 days prior to study drug administration;
barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
vasectomized partner
[Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.]
ii. Facial acne vulgaris in patients with skin of color (Fitzpatrick Type V & VI Supplement VI) characterized by the following:
IGA Score for acne vulgaris 3
IGA Score for PIH 3
iii. Able to understand and comply with the requirements of the study and sign Informed Consent /HIPAA Authorization forms
Exclusion Criteria:
i. Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control
ii. Allergy/sensitivity to any component of the test treatment
iii. IGA score for acne of 2 (mild) or 4 (severe)
iv. IGA score for Post Inflammatory Hyperpigmentation of 2 (mild) or 4 (severe)
v. Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I).
vi. Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study
vii. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris
viii. Evidence of recent alcohol or drug abuse
ix. History of poor cooperation, non-compliance with medical treatment, or unreliability
x. Exposure to an investigational study drug within 30 days of the Baseline Visit
Facility Information:
Facility Name
DermResearch, PLLC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
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