Acne Vulgaris, Post Inflammatory Hyperpigmentation
Conditions
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.
Interventions
DRUGONEXTON Topical Gel
Onexton gel applied once daily to face
Sponsors
Derm Research, PLLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment Scale for Severity of Facial Acne | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Inflammatory Lesions | 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 | 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 | 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 | 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. |
Countries
United States
Participant flow
Pre-assignment details
1 participant signed consent but failed screening
Participants by arm
| Arm | Count |
|---|---|
| Onexton Gel Application Onexton gel (clindamycin phosphate 1.2%/benzoyl peroxide 3.75%) will be supplied to all subjects and applied once daily to the face
ONEXTON Topical Gel: Onexton gel applied once daily to face | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Onexton Gel Application |
|---|---|
| Age, Continuous | 32 years STANDARD_DEVIATION 17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Facial Investigator Global Assessment of Disease Severity Almost Clear | 0 Participants |
| Facial Investigator Global Assessment of Disease Severity Clear | 0 Participants |
| Facial Investigator Global Assessment of Disease Severity Mild | 0 Participants |
| Facial Investigator Global Assessment of Disease Severity Moderate | 20 Participants |
| Facial Investigator Global Assessment of Disease Severity Severe | 0 Participants |
| Inflammatory Lesion Count | 14 lesion STANDARD_DEVIATION 5 |
| Investigator Global Assessment of Severity of Facial Post Inflammatory Hyperpigmentation Mild | 0 Participants |
| Investigator Global Assessment of Severity of Facial Post Inflammatory Hyperpigmentation Moderate | 20 Participants |
| Investigator Global Assessment of Severity of Facial Post Inflammatory Hyperpigmentation Moderately Severe | 0 Participants |
| Investigator Global Assessment of Severity of Facial Post Inflammatory Hyperpigmentation None | 0 Participants |
| Investigator Global Assessment of Severity of Facial Post Inflammatory Hyperpigmentation Slight | 0 Participants |
| Non-Inflammatory Lesion Count | 15 lesion STANDARD_DEVIATION 4 |
| Post Inflammatory Hyperpigmentation Distribution 1-10% | 2 Participants |
| Post Inflammatory Hyperpigmentation Distribution 11-20% | 3 Participants |
| Post Inflammatory Hyperpigmentation Distribution 21-30% | 6 Participants |
| Post Inflammatory Hyperpigmentation Distribution 31-40% | 4 Participants |
| Post Inflammatory Hyperpigmentation Distribution 41-50% | 3 Participants |
| Post Inflammatory Hyperpigmentation Distribution over 50% | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 4 Participants |
| Total Lesion Count | 29 lesion STANDARD_DEVIATION 4 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 10 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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.
Time frame: Week 4, Week 8, Week 16
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Facial Acne | week 4 | clear | 0 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Facial Acne | week 8 | clear | 0 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Facial Acne | week 8 | mild | 12 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Facial Acne | week 8 | moderate | 2 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Facial Acne | week 16 | clear | 1 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Facial Acne | week 16 | almost clear | 13 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Facial Acne | week 16 | mild | 6 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Facial Acne | week 16 | severe | 0 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Facial Acne | week 4 | almost clear | 0 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Facial Acne | week 4 | mild | 11 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Facial Acne | week 4 | moderate | 9 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Facial Acne | week 4 | severe | 0 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Facial Acne | week 8 | almost clear | 6 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Facial Acne | week 8 | severe | 0 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Facial Acne | week 16 | moderate | 0 Participants |
Primary
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
Time frame: Week 4, Week 8, Week 16
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation | week 4 | none | 0 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation | week 4 | slight | 2 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation | week 4 | mild | 17 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation | week 4 | moderate | 1 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation | week 4 | moderately severe | 0 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation | week 8 | none | 0 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation | week 8 | slight | 2 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation | week 8 | mild | 15 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation | week 8 | moderate | 2 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation | week 8 | moderately severe | 1 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation | week 16 | none | 0 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation | week 16 | slight | 8 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation | week 16 | mild | 11 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation | week 16 | moderate | 1 Participants |
| Onexton Gel Application | Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation | week 16 | moderately severe | 0 Participants |
Secondary
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.
Time frame: Week 4, Week 8, Week 16
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Onexton Gel Application | Percent Change in Inflammatory Lesions | Week 4 | -35 percent change | Standard Deviation 17 |
| Onexton Gel Application | Percent Change in Inflammatory Lesions | Week 8 | -55 percent change | Standard Deviation 22 |
| Onexton Gel Application | Percent Change in Inflammatory Lesions | Week 16 | -76 percent change | Standard Deviation 14 |
Secondary
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.
Time frame: Week 4, Week 8, Week 16
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Onexton Gel Application | Percent Change in Non-inflammatory Lesion Count | week 4 | -21 percent change | Standard Deviation 22 |
| Onexton Gel Application | Percent Change in Non-inflammatory Lesion Count | week 8 | -41 percent change | Standard Deviation 33 |
| Onexton Gel Application | Percent Change in Non-inflammatory Lesion Count | week 16 | -62 percent change | Standard Deviation 32 |
Secondary
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.
Time frame: week 4, Week 8, Week 16
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Onexton Gel Application | Percent Change in Total Lesion Count | week 8 | -51 percent change | Standard Deviation 21 |
| Onexton Gel Application | Percent Change in Total Lesion Count | week 16 | -71 percent change | Standard Deviation 13 |
| Onexton Gel Application | Percent Change in Total Lesion Count | week 4 | -29 percent change | Standard Deviation 17 |
Secondary
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.
Time frame: baseline, Week 4, week 8, week 16
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 8 | 2 | 4 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 16 | 4 | 4 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 16 | 5 | 1 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | Baseline | 0 | 0 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | Baseline | 1 | 2 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | Baseline | 2 | 3 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | Baseline | 3 | 6 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | Baseline | 4 | 4 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | Baseline | 5 | 3 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | Baseline | 6 | 2 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 4 | 0 | 0 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 4 | 1 | 2 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 4 | 2 | 3 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 4 | 3 | 7 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 4 | 4 | 3 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 4 | 5 | 3 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 4 | 6 | 2 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 8 | 0 | 0 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 8 | 1 | 2 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 8 | 3 | 8 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 8 | 4 | 3 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 8 | 5 | 2 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 8 | 6 | 1 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 16 | 0 | 0 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 16 | 1 | 5 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 16 | 2 | 5 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 16 | 3 | 5 Participants |
| Onexton Gel Application | Post-Inflammatory Hyperpigmentation (PIH) Distribution | week 16 | 6 | 0 Participants |