Trial Outcomes & Findings for A Study to Evaluate the Tolerance of an Acne Treatment in Sensitive Skin Subjects With Mild to Moderate Acne Vulgaris (NCT NCT03128723)

NCT ID: NCT03128723

Last Updated: 2018-08-31

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 45 participants
• Primary outcome timeframe: Baseline to Day 28
• Results posted on: 2018-08-31

Participant Flow

Recruitment Period: April 04, 2017, to May 10, 2017. Location: Clinical site.

Participant milestones

Measure	Acne Mask 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 Study STARTED	45
Overall Study COMPLETED	43
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Acne Mask 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 Study Withdrawal by Subject	2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Acne Mask n=45 Participants 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.
Age, Continuous	24 Years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 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	2 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	11 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Fitzpatrick skin type I	0 Participants n=5 Participants
Fitzpatrick skin type II	15 Participants n=5 Participants
Fitzpatrick skin type III	11 Participants n=5 Participants
Fitzpatrick skin type IV	6 Participants n=5 Participants
Fitzpatrick skin type V	4 Participants n=5 Participants
Fitzpatrick skin type VI	9 Participants n=5 Participants
Investigator's global acne assessment 0 (clear)	0 Participants n=5 Participants
Investigator's global acne assessment 1 (Almost clear)	0 Participants n=5 Participants
Investigator's global acne assessment 2 (mild)	28 Participants n=5 Participants
Investigator's global acne assessment 3 (moderate)	17 Participants n=5 Participants
Investigator's global acne assessment 4 (severe)	0 Participants n=5 Participants
Do you consider your facial skin to be sensitive? None of the time	0 Participants n=5 Participants
Do you consider your facial skin to be sensitive? Some of the time	0 Participants n=5 Participants
Do you consider your facial skin to be sensitive? Most of the time	26 Participants n=5 Participants
Do you consider your facial skin to be sensitive? All of the time	19 Participants n=5 Participants
In the past, have you ever experienced skin irritation when using topical acne treatments? Yes	38 Participants n=5 Participants
In the past, have you ever experienced skin irritation when using topical acne treatments? No	7 Participants n=5 Participants
In the past, have you ever stopped using a topical acne treatment due to skin irritation Yes	25 Participants n=5 Participants
In the past, have you ever stopped using a topical acne treatment due to skin irritation No	20 Participants n=5 Participants
Have you ever been told by a skin care professional that you have sensitive skin on your face? Yes	15 Participants n=5 Participants
Have you ever been told by a skin care professional that you have sensitive skin on your face? No	30 Participants n=5 Participants
When purchasing skincare products, do you look for products labeled "for sensitive skin" or similar? Yes	42 Participants n=5 Participants
When purchasing skincare products, do you look for products labeled "for sensitive skin" or similar? No	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Day 28

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.

Outcome measures

Measure	Acne Mask n=43 Participants 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.
Cutaneous Tolerance Scores: Erythema	-0.07 Units on a scale Standard Deviation 0.34

PRIMARY outcome

Timeframe: Baseline to Day 28

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.

Outcome measures

Measure	Acne Mask n=43 Participants 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.
Cutaneous Tolerance Scores: Dryness/Scaling	-0.14 Units on a scale Standard Deviation 0.41

PRIMARY outcome

Timeframe: Baseline to Day 28

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.

Outcome measures

Measure	Acne Mask n=43 Participants 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.
Cutaneous Tolerance Scores: Edema	0.00 Units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline to Day 28

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.

Outcome measures

Measure	Acne Mask n=43 Participants 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.
Cutaneous Tolerance Scores: Burning/Stinging	0.00 Units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline to Day 28

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.

Outcome measures

Measure	Acne Mask n=43 Participants 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.
Cutaneous Tolerance Scores: Itching	0.00 Units on a scale Standard Deviation 0.00

PRIMARY outcome

Timeframe: Baseline to Day 28

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.

Outcome measures

Measure	Acne Mask n=43 Participants 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.
Cutaneous Tolerance Scores: Tightness/Dry Feeling	-0.05 Units on a scale Standard Deviation 0.21

SECONDARY outcome

Timeframe: Baseline to Day 14

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.

Outcome measures

Measure	Acne Mask n=45 Participants 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.
Cutaneous Tolerance Scores: Erythema	-0.09 Units on a scale Standard Deviation 0.29

SECONDARY outcome

Timeframe: Baseline to Day 14

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.

Outcome measures

Measure	Acne Mask n=45 Participants 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.
Cutaneous Tolerance Scores: Dryness/Scaling	-0.11 Units on a scale Standard Deviation 0.44

SECONDARY outcome

Timeframe: Baseline to Day 14

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.

Outcome measures

Measure	Acne Mask n=45 Participants 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.
Cutaneous Tolerance Scores: Edema	0.00 Units on a scale Standard Deviation 0.00

SECONDARY outcome

Timeframe: Baseline to Day 14

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.

Outcome measures

Measure	Acne Mask n=45 Participants 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.
Cutaneous Tolerance Scores: Burning/Stinging	0.02 Units on a scale Standard Deviation 0.15

SECONDARY outcome

Timeframe: Baseline to Day 14

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.

Outcome measures

Measure	Acne Mask n=45 Participants 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.
Cutaneous Tolerance Scores: Itching	0.04 Units on a scale Standard Error 0.21

SECONDARY outcome

Timeframe: Baseline to Day 14

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.

Outcome measures

Measure	Acne Mask n=45 Participants 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.
Cutaneous Tolerance Scores: Tightness/Dry	-0.02 Units on a scale Standard Error 0.26

Adverse Events

Acne Mask

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gboyega Adenaike

JnJ Worldwide

Phone: 908-874-1214

Email: aadenaike@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER