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The Use of Onexton in Moderate Acne Vulgaris for Patients With Skin of Color

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ClinicalTrials.gov Identifier: NCT03402893
Recruitment Status : Completed
First Posted : January 18, 2018
Results First Posted : February 19, 2019
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
L.H. Kircik, M.D., Derm Research, PLLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Acne Vulgaris
Post Inflammatory Hyperpigmentation
Intervention Drug: ONEXTON Topical Gel
Enrollment 21
Recruitment Details  
Pre-assignment Details 1 participant signed consent but failed screening
Arm/Group Title Onexton Gel Application
Hide Arm/Group Description

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

Period Title: Overall Study
Started 21
Completed 20
Not Completed 1
Reason Not Completed
Withdrawal by Subject             1
Arm/Group Title Onexton Gel Application
Hide Arm/Group Description

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 Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
32  (17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
16
  80.0%
Male
4
  20.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
20
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
20
 100.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
Facial Investigator Global Assessment of Disease Severity   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Moderate
20
 100.0%
Clear
0
   0.0%
Almost Clear
0
   0.0%
Mild
0
   0.0%
Severe
0
   0.0%
[1]
Measure Description: 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.
Inflammatory Lesion Count  
Mean (Standard Deviation)
Unit of measure:  Lesion
Number Analyzed 20 participants
14  (5)
Non-Inflammatory Lesion Count  
Mean (Standard Deviation)
Unit of measure:  Lesion
Number Analyzed 20 participants
15  (4)
Post Inflammatory Hyperpigmentation Distribution   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
1-10%
2
  10.0%
11-20%
3
  15.0%
21-30%
6
  30.0%
31-40%
4
  20.0%
41-50%
3
  15.0%
over 50%
2
  10.0%
[1]
Measure Description: Each category describes the extent of facial distribution of post-inflammatory hyperpigmentation
Total Lesion Count  
Mean (Standard Deviation)
Unit of measure:  Lesion
Number Analyzed 20 participants
29  (4)
Investigator Global Assessment of Severity of Facial Post Inflammatory Hyperpigmentation   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
None
0
   0.0%
Slight
0
   0.0%
Mild
0
   0.0%
Moderate
20
 100.0%
Moderately Severe
0
   0.0%
[1]
Measure Description: 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.
1.Primary Outcome
Title Investigator Global Assessment Scale for Severity of Facial Acne
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Onexton Gel Application
Hide Arm/Group Description:

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 Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
week 4 clear
0
   0.0%
almost clear
0
   0.0%
mild
11
  55.0%
moderate
9
  45.0%
severe
0
   0.0%
week 8 clear
0
   0.0%
almost clear
6
  30.0%
mild
12
  60.0%
moderate
2
  10.0%
severe
0
   0.0%
week 16 clear
1
   5.0%
almost clear
13
  65.0%
mild
6
  30.0%
moderate
0
   0.0%
severe
0
   0.0%
2.Primary Outcome
Title Investigator Global Assessment Scale for Severity of Post Inflammatory Hyperpigmentation
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Onexton Gel Application
Hide Arm/Group Description:

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 Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
week 4 none
0
   0.0%
slight
2
  10.0%
mild
17
  85.0%
moderate
1
   5.0%
moderately severe
0
   0.0%
week 8 none
0
   0.0%
slight
2
  10.0%
mild
15
  75.0%
moderate
2
  10.0%
moderately severe
1
   5.0%
week 16 none
0
   0.0%
slight
8
  40.0%
mild
11
  55.0%
moderate
1
   5.0%
moderately severe
0
   0.0%
3.Secondary Outcome
Title Percent Change in Inflammatory Lesions
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Onexton Gel Application
Hide Arm/Group Description:

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 Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percent change
Week 4 -35  (17)
Week 8 -55  (22)
Week 16 -76  (14)
4.Secondary Outcome
Title Percent Change in Non-inflammatory Lesion Count
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Onexton Gel Application
Hide Arm/Group Description:

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 Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percent change
week 4 -21  (22)
week 8 -41  (33)
week 16 -62  (32)
5.Secondary Outcome
Title Percent Change in Total Lesion Count
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Onexton Gel Application
Hide Arm/Group Description:

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 Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: percent change
week 4 -29  (17)
week 8 -51  (21)
week 16 -71  (13)
6.Secondary Outcome
Title Post-Inflammatory Hyperpigmentation (PIH) Distribution
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm Onexton Gel Application
Hide Arm/Group Description:

Onexton gel will be supplied to all subjects and applied once daily to the face

ONEXTON Topical Gel: Onexton gel applied once daily to face

Overall Number of Participants Analyzed 20
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline 0
0
   0.0%
1
2
  10.0%
2
3
  15.0%
3
6
  30.0%
4
4
  20.0%
5
3
  15.0%
6
2
  10.0%
week 4 0
0
   0.0%
1
2
  10.0%
2
3
  15.0%
3
7
  35.0%
4
3
  15.0%
5
3
  15.0%
6
2
  10.0%
week 8 0
0
   0.0%
1
2
  10.0%
2
4
  20.0%
3
8
  40.0%
4
3
  15.0%
5
2
  10.0%
6
1
   5.0%
week 16 0
0
   0.0%
1
5
  25.0%
2
5
  25.0%
3
5
  25.0%
4
4
  20.0%
5
1
   5.0%
6
0
   0.0%
Time Frame screening to week 16
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Onexton Gel Application
Hide Arm/Group Description

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

All-Cause Mortality
Onexton Gel Application
Affected / at Risk (%)
Total   0/20 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Onexton Gel Application
Affected / at Risk (%) # Events
Total   0/20 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Onexton Gel Application
Affected / at Risk (%) # Events
Total   10/20 (50.00%)    
Ear and labyrinth disorders   
serous otitis media   1/20 (5.00%)  1
General disorders   
headache   2/20 (10.00%)  2
Infections and infestations   
group A beta hemolytic strep pharyngitis   1/20 (5.00%)  1
cellulitis right knee   1/20 (5.00%)  1
Musculoskeletal and connective tissue disorders   
intermittent mid back pain   1/20 (5.00%)  1
chest soreness   1/20 (5.00%)  1
maxillary fracture   1/20 (5.00%)  1
Reproductive system and breast disorders   
unexpected menses   1/20 (5.00%)  1
bacterial vaginosis   1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders   
bronchitis   1/20 (5.00%)  1
pneumonia   1/20 (5.00%)  1
rhinorrhea   3/20 (15.00%)  3
cough   1/20 (5.00%)  1
upper respiratory infection   2/20 (10.00%)  2
Skin and subcutaneous tissue disorders   
pharyngitis   2/20 (10.00%)  2
facial tattoo tightening   1/20 (5.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: M. McAllister
Organization: Skin Sciences, PLLC
Phone: 5024519000
EMail: mmdermresearch@yahoo.com
Layout table for additonal information
Responsible Party: L.H. Kircik, M.D., Derm Research, PLLC
ClinicalTrials.gov Identifier: NCT03402893     History of Changes
Other Study ID Numbers: ONX-1701
First Submitted: January 11, 2018
First Posted: January 18, 2018
Results First Submitted: January 30, 2019
Results First Posted: February 19, 2019
Last Update Posted: April 2, 2019