Clinical trial NCT03402893: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Post Inflammatory Hyperpigmentation
Lead sponsor: Derm Research, PLLC
Sponsor class: OTHER
First posted: 2018-01-18
Enrollment: 21
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Investigator Global Assessment Scale for Severity of Facial Acne
timeFrame: Week 4, Week 8, Week 16
measure: Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
timeFrame: Week 4, Week 8, Week 16
Secondary outcomes:
measure: Percent Change in Inflammatory Lesions
timeFrame: Week 4, Week 8, Week 16
measure: Percent Change in Non-inflammatory Lesion Count
timeFrame: Week 4, Week 8, Week 16
measure: Percent Change in Total Lesion Count
timeFrame: week 4, Week 8, Week 16
measure: Post-Inflammatory Hyperpigmentation (PIH) Distribution
timeFrame: baseline, Week 4, week 8, week 16
Other outcomes:
Locations:
city: Louisville
country: United States
facility: DermResearch, PLLC
state: Kentucky
Study officials:
References: