Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Tolerance of an Acne Treatment in Sensitive Skin Subjects With Mild to Moderate Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03128723
Recruitment Status : Completed
First Posted : April 25, 2017
Results First Posted : August 31, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne Vulgaris
Intervention Device: Acne Mask
Enrollment 45
Recruitment Details

Recruitment Period: April 04, 2017, to May 10, 2017.

Location: Clinical site.

Pre-assignment Details  
Arm/Group Title Acne Mask
Hide Arm/Group Description The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
Period Title: Overall Study
Started 45
Completed 43
Not Completed 2
Reason Not Completed
Withdrawal by Subject             2
Arm/Group Title Acne Mask
Hide Arm/Group Description The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
Overall Number of Baseline Participants 45
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 45 participants
24  (8.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Female
38
  84.4%
Male
7
  15.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Hispanic or Latino
1
   2.2%
Not Hispanic or Latino
44
  97.8%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
   4.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
11
  24.4%
White
30
  66.7%
More than one race
1
   2.2%
Unknown or Not Reported
1
   2.2%
Fitzpatrick skin type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
I
0
   0.0%
II
15
  33.3%
III
11
  24.4%
IV
6
  13.3%
V
4
   8.9%
VI
9
  20.0%
[1]
Measure Description:

Fitzpatrick skin type range I to VI:

I: White; very fair; red or blonde hair; blue eyes; freckles; Always burns easily; never tans II: White; fair; red or blonde hair; blue hazel, or green eyes; Always burns easily; tans minimally III: Cream white; fair with any eye or hair color; very common; Burns moderately; tans gradually IV: Brown; typical Mediterranean white skin; Burns minimally; always tans well V: Dark brown; mid-eastern skin types, black hair, olive skin; Rarely burns; tans profusely VI: Black; black hair, black eyes, black skin; Never burns; deeply pigmented

Investigator's global acne assessment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
0 (clear)
0
   0.0%
1 (Almost clear)
0
   0.0%
2 (mild)
28
  62.2%
3 (moderate)
17
  37.8%
4 (severe)
0
   0.0%
[1]
Measure Description: Investigator's global acne assessment score 0-4
Do you consider your facial skin to be sensitive?  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
None of the time
0
   0.0%
Some of the time
0
   0.0%
Most of the time
26
  57.8%
All of the time
19
  42.2%
In the past, have you ever experienced skin irritation when using topical acne treatments?  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Yes
38
  84.4%
No
7
  15.6%
In the past, have you ever stopped using a topical acne treatment due to skin irritation  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Yes
25
  55.6%
No
20
  44.4%
Have you ever been told by a skin care professional that you have sensitive skin on your face?  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Yes
15
  33.3%
No
30
  66.7%
When purchasing skincare products, do you look for products labeled “for sensitive skin” or similar?  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants
Yes
42
  93.3%
No
3
   6.7%
1.Primary Outcome
Title Cutaneous Tolerance Scores: Erythema
Hide Description Cutaneous Tolerance Scores: Erythema (assessing skin redness), from Baseline to Day 28. Scale range is 0-3 where 0 = no redness, 1 = mild redness, 2 = moderate redness, and 3 = severe redness.
Time Frame Baseline to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Mask
Hide Arm/Group Description:
The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.07  (0.34)
2.Primary Outcome
Title Cutaneous Tolerance Scores: Dryness/Scaling
Hide Description Cutaneous Tolerance Scores: Dryness/Scaling (assessing skin dryness), from Baseline to Day 28. Scale range is 0-3, where 0 = no dryness, 1 = mild dryness, 2 = moderate dryness, and 3 = severe dryness.
Time Frame Baseline to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Mask
Hide Arm/Group Description:
The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.14  (0.41)
3.Primary Outcome
Title Cutaneous Tolerance Scores: Edema
Hide Description Cutaneous Tolerance Scores: Edema (assessing skin edema/swelling), from Baseline to Day 28. Scale range is 0-3 where 0 = no edema, 1 = mild edema, 2 = moderate edema, and 3 = severe edema.
Time Frame Baseline to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Mask
Hide Arm/Group Description:
The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.00  (0.00)
4.Primary Outcome
Title Cutaneous Tolerance Scores: Burning/Stinging
Hide Description Cutaneous Tolerance Scores: Burning/Stinging (assessing skin burning/stinging), from Baseline to Day 28. Scale range is 0-3 where 0 = no burning/stinging, 1 = mild burning/stinging, 2 = moderate burning/stinging, and 3 = severe burning/stinging.
Time Frame Baseline to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Mask
Hide Arm/Group Description:
The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.00  (0.00)
5.Primary Outcome
Title Cutaneous Tolerance Scores: Itching
Hide Description Cutaneous Tolerance Scores: Itching (assessing skin itching), from Baseline to Day 28. Scale range is 0-3 where 0 = no itching, 1 = mild itching, 2 = moderate itching, and 3 = severe itching.
Time Frame Baseline to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Mask
Hide Arm/Group Description:
The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.00  (0.00)
6.Primary Outcome
Title Cutaneous Tolerance Scores: Tightness/Dry Feeling
Hide Description Cutaneous Tolerance Scores: Tightness/Dry Feeling (assessing skin tightness/dry feeling), from Baseline to Day 28. Scale range is 0-3 where 0 = no tightness/dry feeling, 1 = mild tightness/dry feeling, 2 = moderate tightness/dry feeling, and 3 = severe tightness/dry feeling.
Time Frame Baseline to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Mask
Hide Arm/Group Description:
The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
Overall Number of Participants Analyzed 43
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.05  (0.21)
7.Secondary Outcome
Title Cutaneous Tolerance Scores: Erythema
Hide Description Cutaneous Tolerance Scores: Erythema (assessing skin redness), from Baseline to Day 14. Scale range is 0-3 where 0 = no redness, 1 = mild redness, 2 = moderate redness, and 3 = severe redness.
Time Frame Baseline to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Mask
Hide Arm/Group Description:
The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.09  (0.29)
8.Secondary Outcome
Title Cutaneous Tolerance Scores: Dryness/Scaling
Hide Description Cutaneous Tolerance Scores: Dryness/Scaling (assessing skin dryness), from Baseline to Day 14. Scale range is 0-3, where 0 = no dryness, 1 = mild dryness, 2 = moderate dryness, and 3 = severe dryness.
Time Frame Baseline to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Mask
Hide Arm/Group Description:
The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.11  (0.44)
9.Secondary Outcome
Title Cutaneous Tolerance Scores: Edema
Hide Description Cutaneous Tolerance Scores: Edema (assessing skin edema/swelling), from Baseline to Day 14. Scale range is 0-3 where 0 = no edema, 1 = mild edema, 2 = moderate edema, and 3 = severe edema.
Time Frame Baseline to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Mask
Hide Arm/Group Description:
The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.00  (0.00)
10.Secondary Outcome
Title Cutaneous Tolerance Scores: Burning/Stinging
Hide Description Cutaneous Tolerance Scores: Burning/Stinging (assessing skin burning/stinging), from Baseline to Day 14. Scale range is 0-3 where 0 = no burning/stinging, 1 = mild burning/stinging, 2 = moderate burning/stinging, and 3 = severe burning/stinging.
Time Frame Baseline to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Mask
Hide Arm/Group Description:
The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
Overall Number of Participants Analyzed 45
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.02  (0.15)
11.Secondary Outcome
Title Cutaneous Tolerance Scores: Itching
Hide Description Cutaneous Tolerance Scores: Itching (assessing skin itching), from Baseline to Day 14. Scale range is 0-3 where 0 = no itching, 1 = mild itching, 2 = moderate itching, and 3 = severe itching.
Time Frame Baseline to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Mask
Hide Arm/Group Description:
The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
Overall Number of Participants Analyzed 45
Mean (Standard Error)
Unit of Measure: Units on a scale
0.04  (0.21)
12.Secondary Outcome
Title Cutaneous Tolerance Scores: Tightness/Dry
Hide Description Cutaneous Tolerance Scores: Tightness/Dry Feeling (assessing skin tightness/dry feeling), from Baseline to Day 14. Scale range is 0-3 where 0 = no tightness/dry feeling, 1 = mild tightness/dry feeling, 2 = moderate tightness/dry feeling, and 3 = severe tightness/dry feeling.
Time Frame Baseline to Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Acne Mask
Hide Arm/Group Description:
The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
Overall Number of Participants Analyzed 45
Mean (Standard Error)
Unit of Measure: Units on a scale
-0.02  (0.26)
Time Frame Adverse events were reported from the time a signed and dated informed consent was obtained at Baseline until Day 28 or subject's last visit. Serious adverse events were also reportable within 30 calendar days of subject's last visit. Spontaneously reported seriously adverse events after the 30 calendar days period assessed by the investigator to be study related would be reportable to the Sponsor.
Adverse Event Reporting Description The investigator or a designee interviewed subjects for changes in health/medication at each visit, documenting any reported adverse events.
 
Arm/Group Title Acne Mask
Hide Arm/Group Description The light therapy acne mask is applied to the face once in the evening for a duration of 10 minutes. The cleanser is used twice daily, once in the morning and once in the evening.
All-Cause Mortality
Acne Mask
Affected / at Risk (%)
Total   0/45 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Acne Mask
Affected / at Risk (%)
Total   0/45 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Acne Mask
Affected / at Risk (%)
Total   0/45 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
Prior to submission for any public disclosure of the data or results, the PI will provide the Sponsor with at least 60 days for review of the publication. Sponsor's written consent is required for any publication containing the Sponsor's confidential information. The Sponsor may request that the PI withholds such publication for up to an additional 60 days to allow for filing of a patent application.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gboyega Adenaike
Organization: JnJ Worldwide
Phone: 908-874-1214
EMail: aadenaike@its.jnj.com
Layout table for additonal information
Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) )
ClinicalTrials.gov Identifier: NCT03128723     History of Changes
Other Study ID Numbers: CO-170125113728-SACT
First Submitted: April 20, 2017
First Posted: April 25, 2017
Results First Submitted: June 6, 2018
Results First Posted: August 31, 2018
Last Update Posted: August 31, 2018