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. Identifier: NCT03402893
Recruitment Status : Completed
First Posted : January 18, 2018
Last Update Posted : May 22, 2018
Information provided by (Responsible Party):
Leon Kircik, M.D., Derm Research, PLLC

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Post Inflammatory Hyperpigmentation Drug: ONEXTON Topical Gel Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
Actual Study Start Date : July 28, 2017
Actual Primary Completion Date : November 15, 2017
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: single arm Onexton gel application
Onexton gel will be supplied to all subjects and applied once daily to the face
Drug: ONEXTON Topical Gel
Onexton gel applied once daily to face

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. inflammatory lesion count [ Time Frame: Baseline- Week 16 ]
    percent reduction in inflammatory lesion count-

  2. non-inflammatory lesion count [ Time Frame: Baseline - Week 16 ]
    percent reduction in non-inflammatory lesion count

  3. total lesion count [ Time Frame: Baseline - Week 16 ]
    percent reduction in total lesion count

  4. Post-inflammatory hyperpigmentation distribution [ Time Frame: Baseline - Week 16 ]
    change in distribution of post-inflammatory hyperpigmentation

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 PIH 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03402893

United States, Kentucky
DermResearch, PLLC
Louisville, Kentucky, United States, 40217
Sponsors and Collaborators
Derm Research, PLLC

Responsible Party: Leon Kircik, M.D., Medical Director, Derm Research, PLLC Identifier: NCT03402893     History of Changes
Other Study ID Numbers: ONX-1701
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018

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

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Pigmentation Disorders
Benzoyl Peroxide
Dermatologic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action