Trial Outcomes & Findings for A Study to Evaluate the Effectiveness and Tolerance of Two Acne Treatments on Subjects With Mild to Moderate Acne. (NCT NCT02698436)

NCT ID: NCT02698436

Last Updated: 2018-01-23

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 103 participants
• Primary outcome timeframe: Baseline to 12 Weeks
• Results posted on: 2018-01-23

Participant Flow

Participant milestones

Measure	Acne Mask Light therapy mask applied to the face once in the evening for a duration of 10 minutes	Benzoyl Peroxide 2.5% Apply test product to face once in the morning and once at night.
Overall Study STARTED	59	58
Overall Study COMPLETED	52	51
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Measure	Acne Mask Light therapy mask applied to the face once in the evening for a duration of 10 minutes	Benzoyl Peroxide 2.5% Apply test product to face once in the morning and once at night.
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	3	3
Overall Study Lost to Follow-up	2	4
Overall Study Non-compliance with study regimen	1	0

Baseline Characteristics

A Study to Evaluate the Effectiveness and Tolerance of Two Acne Treatments on Subjects With Mild to Moderate Acne.

Baseline characteristics by cohort

Measure	Acne Mask n=59 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide Treatment n=58 Participants Applied BPO treatment once daily	Total n=117 Participants Total of all reporting groups
Age, Continuous	17.8 years STANDARD_DEVIATION 5.79 • n=5 Participants	18.7 years STANDARD_DEVIATION 5.97 • n=7 Participants	18.2 years STANDARD_DEVIATION 5.87 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	28 Participants n=5 Participants	27 Participants n=7 Participants	55 Participants n=5 Participants
Region of Enrollment USA	59 participants n=5 Participants	58 participants n=7 Participants	117 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 12 Weeks

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Outcome measures

Measure	Acne Mask n=55 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=54 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Percent Change of Global Face Total Acne Lesion Count From Baseline	-44 Percent change of acne lesion count Interval -51.0 to -37.0	-54 Percent change of acne lesion count Interval -61.0 to -45.0

SECONDARY outcome

Timeframe: Baseline to 1 Week

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Outcome measures

Measure	Acne Mask n=54 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=54 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 1	-19 Percent change of acne lesion count Interval -25.0 to -13.0	-26 Percent change of acne lesion count Interval -33.0 to -19.0

SECONDARY outcome

Timeframe: Baseline to 2 Weeks

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Outcome measures

Measure	Acne Mask n=52 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=52 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 2	-28 Percent change of acne lesion count Interval -35.0 to -21.0	-42 Percent change of acne lesion count Interval -48.0 to -35.0

SECONDARY outcome

Timeframe: Baseline to 4 Weeks

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Outcome measures

Measure	Acne Mask n=54 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=52 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 4	-35 Percent change of acne lesion count Interval -42.0 to -27.0	-46 Percent change of acne lesion count Interval -53.0 to -39.0

SECONDARY outcome

Timeframe: Baseline to 8 Weeks

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Outcome measures

Measure	Acne Mask n=52 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=51 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Percent Change of Global Face Total Acne Lesion Count From Baseline to Week 8	-40 Percent change of acne lesion count Interval -46.0 to -33.0	-50 Percent change of acne lesion count Interval -62.0 to -38.0

SECONDARY outcome

Timeframe: Baseline

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Acne Lesion Count Total Global Face at Baseline

Outcome measures

Measure	Acne Mask n=55 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=54 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Acne Lesion Counts Total Global Face - Baseline	47.2 Lesion Count Standard Deviation 22.56	47.6 Lesion Count Standard Deviation 23.22

SECONDARY outcome

Timeframe: 1 Week

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Acne Lesion Count Total Global Face Week 1

Outcome measures

Measure	Acne Mask n=54 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=54 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Acne Lesion Counts Total Global Face - Week 1	39.2 Lesion Count Standard Deviation 22.5	36.8 Lesion Count Standard Deviation 24.00

SECONDARY outcome

Timeframe: 2 Weeks

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Acne Lesion Count Total Global Face Week 2

Outcome measures

Measure	Acne Mask n=52 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=52 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Acne Lesion Counts Total Global Face - Week 2	35.3 Lesion Count Standard Deviation 20.13	30.5 Lesion Count Standard Deviation 22.88

SECONDARY outcome

Timeframe: 4 Weeks

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Acne Lesion Count Total Global Face Week 4

Outcome measures

Measure	Acne Mask n=54 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=52 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Acne Lesion Counts Total Global Face - Week 4	30.5 Lesion Count Standard Deviation 17.51	27.0 Lesion Count Standard Deviation 19.76

SECONDARY outcome

Timeframe: 8 Weeks

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Acne Lesion Count Total Global Face Week 8

Outcome measures

Measure	Acne Mask n=52 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=51 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Acne Lesion Counts Total Global Face - Week 8	27.8 Lesion Count Standard Deviation 16.06	26.4 Lesion Count Standard Deviation 28.40

SECONDARY outcome

Timeframe: 12 Weeks

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Acne Lesion Count Total Global Face Week 12

Outcome measures

Measure	Acne Mask n=52 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=51 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Acne Lesion Counts Total Global Face - Week 12	24.8 Lesion Count Standard Deviation 15.76	23.3 Lesion Count Standard Deviation 20.91

SECONDARY outcome

Timeframe: Baseline

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.

0 Clear Residual hyperpigmentation and erythema may be present.

1. Almost Clear. A few scattered comedones and a few (less than five) small papules.

2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.

3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.

4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.

5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.

Outcome measures

Measure	Acne Mask n=55 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=54 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Investigator Global Acne Assessment - Baseline	2.55 Score on a scale Standard Deviation 0.529	2.51 Score on a scale Standard Deviation 0.471

SECONDARY outcome

Timeframe: 1 Week

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.

0 Clear Residual hyperpigmentation and erythema may be present.

1. Almost Clear. A few scattered comedones and a few (less than five) small papules.

2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.

3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.

4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.

5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.

Outcome measures

Measure	Acne Mask n=54 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=54 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Investigator Global Acne Assessment - Week 1	2.35 Score on a scale Standard Deviation 0.538	2.34 Score on a scale Standard Deviation 0.548

SECONDARY outcome

Timeframe: 2 Weeks

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.

0 Clear Residual hyperpigmentation and erythema may be present.

1. Almost Clear. A few scattered comedones and a few (less than five) small papules.

2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.

3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.

4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.

5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.

Outcome measures

Measure	Acne Mask n=52 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=52 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Investigator Global Acne Assessment - Week 2	2.23 Score on a scale Standard Deviation 0.598	2.11 Score on a scale Standard Deviation 0.605

SECONDARY outcome

Timeframe: 4 Weeks

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.

0 Clear Residual hyperpigmentation and erythema may be present.

1. Almost Clear. A few scattered comedones and a few (less than five) small papules.

2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.

3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.

4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.

5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.

Outcome measures

Measure	Acne Mask n=54 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=52 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Investigator Global Acne Assessment - Week 4	2.08 Score on a scale Standard Deviation 0.612	1.87 Score on a scale Standard Deviation 0.650

SECONDARY outcome

Timeframe: 8 Weeks

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.

0 Clear Residual hyperpigmentation and erythema may be present.

1. Almost Clear. A few scattered comedones and a few (less than five) small papules.

2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.

3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.

4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.

5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.

Outcome measures

Measure	Acne Mask n=52 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=51 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Investigator Global Acne Assessment - Week 8	1.88 Score on a scale Standard Deviation 0.583	1.70 Score on a scale Standard Deviation 0.775

SECONDARY outcome

Timeframe: 12 Weeks

Population: Includes all subjects who had measurements taken at this time point. Some subjects may have missed the visit, or had a protocol deviation that would exclude their data.

Investigator's assessment of subject's acne condition using a score of 0 (best) and 5 (worst) on the Modified Cook's scale.

0 Clear Residual hyperpigmentation and erythema may be present.

1. Almost Clear. A few scattered comedones and a few (less than five) small papules.

2. Mild.Easily recognizable; less than half the face is involved. Many comedones and many papules and pustules.

3. Moderate More than half of the face is involved. Numerous comedones, papules and pustules.

4. Severe. Entire face is involved. Covered with comedones, numerous papules and pustules and few nodules and cysts.

5. Very Severe.Highly inflammatory acne covering the face; with nodules and cysts present.

Outcome measures

Measure	Acne Mask n=52 Participants Light therapy mask applied to the face once in the evening for a duration of 10 minutes	2.5% Benzoyl Peroxide n=51 Participants Both 2.5% BPO cleanser and treatment are applied twice daily, once in the moring and once in the evening
Investigator Global Acne Assessment - Week 12	1.77 Score on a scale Standard Deviation 0.660	1.59 Score on a scale Standard Deviation 0.726

Adverse Events

Acne Mask

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

2.5% Benzoyl Peroxide Treatment

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

Lisa Fitzgerald

JNJWorldwide

Phone: +1 908-904-6235

Email: lfitzge6@its.jnj.com

Results disclosure agreements

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