Trial Outcomes & Findings for The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color (NCT NCT03402893)
NCT ID: NCT03402893
Last Updated: 2019-04-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
21 participants
Primary outcome timeframe
Week 4, Week 8, Week 16
Results posted on
2019-04-02
Participant Flow
1 participant signed consent but failed screening
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
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
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color
Baseline characteristics by cohort
| Measure |
Onexton Gel Application
n=20 Participants
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
|
|---|---|
|
Age, Continuous
|
32 years
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=5 Participants
|
|
Facial Investigator Global Assessment of Disease Severity
Moderate
|
20 Participants
n=5 Participants
|
|
Facial Investigator Global Assessment of Disease Severity
Clear
|
0 Participants
n=5 Participants
|
|
Facial Investigator Global Assessment of Disease Severity
Almost Clear
|
0 Participants
n=5 Participants
|
|
Facial Investigator Global Assessment of Disease Severity
Mild
|
0 Participants
n=5 Participants
|
|
Facial Investigator Global Assessment of Disease Severity
Severe
|
0 Participants
n=5 Participants
|
|
Inflammatory Lesion Count
|
14 lesion
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Non-Inflammatory Lesion Count
|
15 lesion
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Post Inflammatory Hyperpigmentation Distribution
1-10%
|
2 Participants
n=5 Participants
|
|
Post Inflammatory Hyperpigmentation Distribution
11-20%
|
3 Participants
n=5 Participants
|
|
Post Inflammatory Hyperpigmentation Distribution
21-30%
|
6 Participants
n=5 Participants
|
|
Post Inflammatory Hyperpigmentation Distribution
31-40%
|
4 Participants
n=5 Participants
|
|
Post Inflammatory Hyperpigmentation Distribution
41-50%
|
3 Participants
n=5 Participants
|
|
Post Inflammatory Hyperpigmentation Distribution
over 50%
|
2 Participants
n=5 Participants
|
|
Total Lesion Count
|
29 lesion
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Investigator Global Assessment of Severity of Facial Post Inflammatory Hyperpigmentation
None
|
0 Participants
n=5 Participants
|
|
Investigator Global Assessment of Severity of Facial Post Inflammatory Hyperpigmentation
Slight
|
0 Participants
n=5 Participants
|
|
Investigator Global Assessment of Severity of Facial Post Inflammatory Hyperpigmentation
Mild
|
0 Participants
n=5 Participants
|
|
Investigator Global Assessment of Severity of Facial Post Inflammatory Hyperpigmentation
Moderate
|
20 Participants
n=5 Participants
|
|
Investigator Global Assessment of Severity of Facial Post Inflammatory Hyperpigmentation
Moderately Severe
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4, Week 8, Week 16Percent 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.
Outcome measures
| Measure |
Onexton Gel Application
n=20 Participants
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
|
|---|---|
|
Investigator Global Assessment Scale for Severity of Facial Acne
week 4 · clear
|
0 Participants
|
|
Investigator Global Assessment Scale for Severity of Facial Acne
week 4 · almost clear
|
0 Participants
|
|
Investigator Global Assessment Scale for Severity of Facial Acne
week 4 · mild
|
11 Participants
|
|
Investigator Global Assessment Scale for Severity of Facial Acne
week 4 · moderate
|
9 Participants
|
|
Investigator Global Assessment Scale for Severity of Facial Acne
week 4 · severe
|
0 Participants
|
|
Investigator Global Assessment Scale for Severity of Facial Acne
week 8 · clear
|
0 Participants
|
|
Investigator Global Assessment Scale for Severity of Facial Acne
week 8 · almost clear
|
6 Participants
|
|
Investigator Global Assessment Scale for Severity of Facial Acne
week 8 · mild
|
12 Participants
|
|
Investigator Global Assessment Scale for Severity of Facial Acne
week 8 · moderate
|
2 Participants
|
|
Investigator Global Assessment Scale for Severity of Facial Acne
week 8 · severe
|
0 Participants
|
|
Investigator Global Assessment Scale for Severity of Facial Acne
week 16 · clear
|
1 Participants
|
|
Investigator Global Assessment Scale for Severity of Facial Acne
week 16 · almost clear
|
13 Participants
|
|
Investigator Global Assessment Scale for Severity of Facial Acne
week 16 · mild
|
6 Participants
|
|
Investigator Global Assessment Scale for Severity of Facial Acne
week 16 · moderate
|
0 Participants
|
|
Investigator Global Assessment Scale for Severity of Facial Acne
week 16 · severe
|
0 Participants
|
PRIMARY outcome
Timeframe: Week 4, Week 8, Week 16Percent 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
Outcome measures
| Measure |
Onexton Gel Application
n=20 Participants
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
|
|---|---|
|
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
week 4 · none
|
0 Participants
|
|
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
week 4 · slight
|
2 Participants
|
|
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
week 4 · mild
|
17 Participants
|
|
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
week 4 · moderate
|
1 Participants
|
|
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
week 4 · moderately severe
|
0 Participants
|
|
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
week 8 · none
|
0 Participants
|
|
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
week 8 · slight
|
2 Participants
|
|
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
week 8 · mild
|
15 Participants
|
|
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
week 8 · moderate
|
2 Participants
|
|
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
week 8 · moderately severe
|
1 Participants
|
|
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
week 16 · none
|
0 Participants
|
|
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
week 16 · slight
|
8 Participants
|
|
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
week 16 · mild
|
11 Participants
|
|
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
week 16 · moderate
|
1 Participants
|
|
Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
week 16 · moderately severe
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 16The 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.
Outcome measures
| Measure |
Onexton Gel Application
n=20 Participants
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
|
|---|---|
|
Percent Change in Inflammatory Lesions
Week 4
|
-35 percent change
Standard Deviation 17
|
|
Percent Change in Inflammatory Lesions
Week 8
|
-55 percent change
Standard Deviation 22
|
|
Percent Change in Inflammatory Lesions
Week 16
|
-76 percent change
Standard Deviation 14
|
SECONDARY outcome
Timeframe: Week 4, Week 8, Week 16The Investigator will count the number of facial non-inflammatory acne lesions at each study visit. these include open and closed comedones.
Outcome measures
| Measure |
Onexton Gel Application
n=20 Participants
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
|
|---|---|
|
Percent Change in Non-inflammatory Lesion Count
week 4
|
-21 percent change
Standard Deviation 22
|
|
Percent Change in Non-inflammatory Lesion Count
week 8
|
-41 percent change
Standard Deviation 33
|
|
Percent Change in Non-inflammatory Lesion Count
week 16
|
-62 percent change
Standard Deviation 32
|
SECONDARY outcome
Timeframe: week 4, Week 8, Week 16The 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.
Outcome measures
| Measure |
Onexton Gel Application
n=20 Participants
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
|
|---|---|
|
Percent Change in Total Lesion Count
week 4
|
-29 percent change
Standard Deviation 17
|
|
Percent Change in Total Lesion Count
week 8
|
-51 percent change
Standard Deviation 21
|
|
Percent Change in Total Lesion Count
week 16
|
-71 percent change
Standard Deviation 13
|
SECONDARY outcome
Timeframe: baseline, Week 4, week 8, week 16This 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.
Outcome measures
| Measure |
Onexton Gel Application
n=20 Participants
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
|
|---|---|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
Baseline · 6
|
2 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 4 · 0
|
0 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
Baseline · 0
|
0 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
Baseline · 1
|
2 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
Baseline · 2
|
3 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
Baseline · 3
|
6 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
Baseline · 4
|
4 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
Baseline · 5
|
3 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 4 · 1
|
2 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 4 · 2
|
3 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 4 · 3
|
7 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 4 · 4
|
3 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 4 · 5
|
3 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 4 · 6
|
2 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 8 · 0
|
0 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 8 · 1
|
2 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 8 · 2
|
4 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 8 · 3
|
8 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 8 · 4
|
3 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 8 · 5
|
2 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 8 · 6
|
1 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 16 · 0
|
0 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 16 · 1
|
5 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 16 · 2
|
5 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 16 · 3
|
5 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 16 · 4
|
4 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 16 · 5
|
1 Participants
|
|
Post-Inflammatory Hyperpigmentation (PIH) Distribution
week 16 · 6
|
0 Participants
|
Adverse Events
Onexton Gel Application
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Onexton Gel Application
n=20 participants at risk
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
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
10.0%
2/20 • Number of events 2 • screening to week 16
|
|
Musculoskeletal and connective tissue disorders
maxillary fracture
|
5.0%
1/20 • Number of events 1 • screening to week 16
|
|
General disorders
headache
|
10.0%
2/20 • Number of events 2 • screening to week 16
|
|
Musculoskeletal and connective tissue disorders
intermittent mid back pain
|
5.0%
1/20 • Number of events 1 • screening to week 16
|
|
Infections and infestations
group A beta hemolytic strep pharyngitis
|
5.0%
1/20 • Number of events 1 • screening to week 16
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis
|
5.0%
1/20 • Number of events 1 • screening to week 16
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
5.0%
1/20 • Number of events 1 • screening to week 16
|
|
Infections and infestations
cellulitis right knee
|
5.0%
1/20 • Number of events 1 • screening to week 16
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhea
|
15.0%
3/20 • Number of events 3 • screening to week 16
|
|
Skin and subcutaneous tissue disorders
pharyngitis
|
10.0%
2/20 • Number of events 2 • screening to week 16
|
|
Reproductive system and breast disorders
unexpected menses
|
5.0%
1/20 • Number of events 1 • screening to week 16
|
|
Skin and subcutaneous tissue disorders
facial tattoo tightening
|
5.0%
1/20 • Number of events 1 • screening to week 16
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
5.0%
1/20 • Number of events 1 • screening to week 16
|
|
Musculoskeletal and connective tissue disorders
chest soreness
|
5.0%
1/20 • Number of events 1 • screening to week 16
|
|
Ear and labyrinth disorders
serous otitis media
|
5.0%
1/20 • Number of events 1 • screening to week 16
|
|
Reproductive system and breast disorders
bacterial vaginosis
|
5.0%
1/20 • Number of events 1 • screening to week 16
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place