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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm Onexton gel application | Experimental | Onexton gel will be supplied to all subjects and applied once daily to the face |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONEXTON Topical Gel | Drug | Onexton gel applied once daily to face |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4, Week 8, Week 16 |
| 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 | Week 4, Week 8, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4, Week 8, Week 16 |
| Percent Change in Non-inflammatory Lesion Count |
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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:
Reliable methods of contraception are:
[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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DermResearch, PLLC | Louisville | Kentucky | 40217 | United States |
1 participant signed consent but failed screening
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Week 4, Week 8, Week 16 |
|
screening to week 16
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| intermittent mid back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. McAllister | Skin Sciences, PLLC | 5024519000 | mmdermresearch@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jun 12, 2017 | Jan 25, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2017 | Jan 30, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| D017495 | Hyperpigmentation |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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The Investigator will count the number of facial non-inflammatory acne lesions at each study visit. these include open and closed comedones. |
| Week 4, Week 8, Week 16 |
| 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. | week 4, Week 8, Week 16 |
| 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. | baseline, Week 4, week 8, week 16 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Facial Investigator Global Assessment of Disease Severity | This assessment measures the severity of acne. The minimum value is 0/Absent and the maximum value is 5/severe. The data is reported as the percentage of patients who fall into each category at each time point. | Count of Participants | Participants |
|
| Inflammatory Lesion Count | Mean | Standard Deviation | lesion |
|
| Non-Inflammatory Lesion Count | Mean | Standard Deviation | lesion |
|
| Post Inflammatory Hyperpigmentation Distribution | Each category describes the extent of facial distribution of post-inflammatory hyperpigmentation | Count of Participants | Participants |
|
| Total Lesion Count | Mean | Standard Deviation | lesion |
|
| Investigator Global Assessment of Severity of Facial Post Inflammatory Hyperpigmentation | This assessment measures the severity of facial post-inflammatory hyperpigmentation. The minimum value is None and the maximum is Moderately Severe. The results are reported as the number of subjects falling under each category and the corresponding percentage of total participants falling under each category. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| 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 | Posted | Count of Participants | Participants | Week 4, Week 8, Week 16 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percent change | Week 4, Week 8, Week 16 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percent change | Week 4, Week 8, Week 16 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | percent change | week 4, Week 8, Week 16 |
|
|
|
| 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. | Posted | Count of Participants | Participants | baseline, Week 4, week 8, week 16 |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 10 |
| 20 |
| group A beta hemolytic strep pharyngitis | Infections and infestations | Systematic Assessment |
|
| bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| cellulitis right knee | Infections and infestations | Systematic Assessment |
|
| rhinorrhea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pharyngitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| unexpected menses | Reproductive system and breast disorders | Systematic Assessment |
|
| facial tattoo tightening | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| chest soreness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| serous otitis media | Ear and labyrinth disorders | Systematic Assessment |
|
| bacterial vaginosis | Reproductive system and breast disorders | Systematic Assessment |
|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| maxillary fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| headache | General disorders | Systematic Assessment |
|
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| D010859 | Pigmentation Disorders |
|
| severe |
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| severe |
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| moderate |
|
| moderately severe |
|
| week 8 |
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| week 16 |
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| 3 |
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| 4 |
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| 5 |
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| 6 |
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| week 4 |
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| week 8 |
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| week 16 |
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