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The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03402893
Recruitment Status : Completed
First Posted : January 18, 2018
Results First Posted : February 19, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
L.H. Kircik, M.D., Derm Research, PLLC

Tracking Information
First Submitted Date  ICMJE January 11, 2018
First Posted Date  ICMJE January 18, 2018
Results First Submitted Date  ICMJE January 30, 2019
Results First Posted Date  ICMJE February 19, 2019
Last Update Posted Date April 2, 2019
Actual Study Start Date  ICMJE July 28, 2017
Actual Primary Completion Date November 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 30, 2019)
  • Investigator Global Assessment Scale for Severity of Facial Acne [ Time Frame: Week 4, Week 8, Week 16 ]
    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 [ Time Frame: Week 4, Week 8, Week 16 ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2018)
Investigator Global Assessment Scale for acne and Post-Inflammatory Hyperpigmentation (PIH) [ Time Frame: Baseline - Week 16 ]
Percent of subjects achieving clear or almost clear on Investigator's Global Assessment (IGA) scale for acne and PIH; 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. PIH severity is also assessed by the Investigator on a scale of 0 to 6 with 0 = None, 1 = Slight severity, 2 = Mild, 3 = Moderate, 4 = Moderately Severe, 5 = Severe, 6 = Very Severe
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
  • Percent Change in Inflammatory Lesions [ Time Frame: Week 4, Week 8, Week 16 ]
    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 [ Time Frame: Week 4, Week 8, Week 16 ]
    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 [ Time Frame: week 4, Week 8, Week 16 ]
    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 [ Time Frame: baseline, Week 4, week 8, week 16 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2018)
  • Inflammatory Lesion Count [ Time Frame: Baseline- Week 16 ]
    percent reduction in inflammatory lesion count-
  • Non-inflammatory Lesion Count [ Time Frame: Baseline - Week 16 ]
    percent reduction in non-inflammatory lesion count
  • Total Lesion Count [ Time Frame: Baseline - Week 16 ]
    percent reduction in total lesion count
  • Post-inflammatory Hyperpigmentation Distribution [ Time Frame: Baseline - Week 16 ]
    change in distribution of post-inflammatory hyperpigmentation
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
Official Title  ICMJE The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acne Vulgaris
  • Post Inflammatory Hyperpigmentation
Intervention  ICMJE Drug: ONEXTON Topical Gel
Onexton gel applied once daily to face
Study Arms  ICMJE Experimental: single arm Onexton gel application
Onexton gel will be supplied to all subjects and applied once daily to the face
Intervention: Drug: ONEXTON Topical Gel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2019)
21
Original Actual Enrollment  ICMJE
 (submitted: January 17, 2018)
20
Actual Study Completion Date  ICMJE February 28, 2018
Actual Primary Completion Date November 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03402893
Other Study ID Numbers  ICMJE ONX-1701
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party L.H. Kircik, M.D., Derm Research, PLLC
Study Sponsor  ICMJE Derm Research, PLLC
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Derm Research, PLLC
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP