N/A N=126 Randomized Double-blind Treatment

A Study to Evaluate the Efficacy and Tolerance of 2 Acne Treatment Regimens on Subjects With Mild to Moderate Acne

Acne Vulgaris

Bottom Line

View on ClinicalTrials.gov: NCT03124381 ↗

Enrolled (actual)

126

Serious AEs

0.0%

Results posted

Nov 2018

Primary outcome: Primary: Global Face Total Lesion Count - Percent Change - Baseline to Week 12 — -42.64; -47.80 Percent Change in Lesions — p=0.538

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Cleanser, Acne Mask (Device); Cleanser, Gel-Cream, Acne Mask (Device)
Age: Pediatric, Adult · 12+ yrs
Sex: All
Sponsor: Johnson & Johnson Consumer Inc. (J&JCI)
Primary completion: Sep 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Global Face Total Lesion Count - Percent Change - Baseline to Week 12	-42.64; -47.80	0.538
SECONDARY Global Face Total Lesion Count - Percent Change - Baseline to Week 2	-24.16; -27.97	—
SECONDARY Global Face Total Lesion Count - Percent Change - Baseline to Week 4	-29.78; -38.25	—
SECONDARY Global Face Total Lesion Count - Percent Change - Baseline to Week 8	-39.81; -45.86	—
SECONDARY Global Face Total Lesion Count - Percent Change From Baseline to the Mean of All Visits	-33.68; -39.79	—
SECONDARY Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 2 and Week 4	-26.95; -33.01	—
SECONDARY Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 4 and Week 8	-34.34; -42.09	—
SECONDARY Global Face Total Lesion Count - Percent Change From Baseline to the Mean of Week 8 and Week 12	-41.73; -47.25	—
SECONDARY Global Face Open Comedones Count - Week 2	8.1; 5.6	—
SECONDARY Global Face Open Comedones Count - Week 4	7.9; 5.3	—
SECONDARY Global Face Open Comedones Count - Week 8	5.1; 4.5	—
SECONDARY Global Face Open Comedones Count - Week 12	3.6; 3.7	—
SECONDARY Global Face Closed Comedones Count - Week 2	14.7; 12.7	—
SECONDARY Global Face Closed Comedones Count - Week 4	14.1; 10.9	—
SECONDARY Global Face Closed Comedones Count - Week 8	12.7; 10.3	—
SECONDARY Global Face Closed Comedones Count - Week 12	11.9; 10.2	—
SECONDARY Global Face Inflammatory Lesion Count - Week 2	12.1; 10.3	—
SECONDARY Global Face Inflammatory Lesion Count - Week 4	10.8; 9.1	—
SECONDARY Global Face Inflammatory Lesion Count - Week 8	9.9; 7.8	—
SECONDARY Global Face Inflammatory Lesion Count - Week 12	9.7; 7.7	—
SECONDARY Global Face Non-Inflammatory Lesion Count - Week 2	22.7; 18.3	—
SECONDARY Global Face Non-Inflammatory Lesion Count - Week 4	22.0; 16.2	—
SECONDARY Global Face Non-Inflammatory Lesion Count - Week 8	17.8; 14.8	—
SECONDARY Global Face Non-Inflammatory Lesion Count - Week 12	15.6; 14.0	—
SECONDARY Global Face Total Lesion Count - Week 2	34.8; 28.6	—
SECONDARY Global Face Total Lesion Count - Week 4	32.8; 25.2	—
SECONDARY Global Face Total Lesion Count - Week 8	27.7; 22.5	—
SECONDARY Global Face Total Lesion Count - Week 12	25.3; 21.7	—
SECONDARY Investigator Global Acne Assessment - Week 1	2.29; 2.27	—
SECONDARY Investigator Global Acne Assessment - Week 2	2.17; 2.06	—
SECONDARY Investigator Global Acne Assessment - Week 4	2.00; 1.90	—
SECONDARY Investigator Global Acne Assessment - Week 8	1.84; 1.73	—
SECONDARY Investigator Global Acne Assessment - Week 12	1.64; 1.64	—
SECONDARY Overall Redness of Inflammatory Lesions - Week 1	4.88; 5.05	—
SECONDARY Overall Redness of Inflammatory Lesions - Week 2	4.65; 4.74	—
SECONDARY Overall Redness of Inflammatory Lesions - Week 4	4.49; 4.41	—
SECONDARY Overall Redness of Inflammatory Lesions - Week 8	4.30; 4.25	—
SECONDARY Overall Redness of Inflammatory Lesions - Week 12	3.96; 3.97	—
SECONDARY Overall Size of Inflammatory Lesions - Week 1	4.58; 4.83	—
SECONDARY Overall Size of Inflammatory Lesions - Week 2	4.17; 4.56	—
SECONDARY Overall Size of Inflammatory Lesions - Week 4	4.07; 4.15	—
SECONDARY Overall Size of Inflammatory Lesions - Week 8	3.88; 3.85	—
SECONDARY Overall Size of Inflammatory Lesions - Week 12	3.67; 3.59	—

Summary

This study will compare two different acne treatment regimens for the treatment of acne. Half of participants will receive a cleanser and a light therapy mask, while half of the participants will receive a cleanser, a light therapy topical gel-cream, and a light therapy mask.

Eligibility Criteria

Inclusion Criteria

Has mild to moderate facial acne
Has 10-100 blackheads/whiteheads, 10-50 pimples, no cysts, and up to 2 large, hard, painful bumps (nodules)
Able to read, write, speak, and understand English
In general good health
Must agree to practice a medically acceptable form of birth control.
Intends to complete the study and willing to follow all study instructions.

Exclusion Criteria

Very sensitive skin or allergies/sensitivity to skincare products or the test product ingredients.
Has a light or photosensitivity disorder or another medical condition that could increase risk to the subject or confuse the study results
Is using medication that makes skin more sensitive to light
Has severe acne or a pre-existing facial skin condition other than mild to moderate acne
has an immune deficiency disorder
has been using a product or medication that the stuff investigator determines will increase health risk to the subject or confuse the study results
Females that are pregnant, nursing, or planning to become pregnant
Males with a female partner who is pregnant or planning to become pregnant
Has excessive facial hair
Is participating in another study within past 4 weeks
Is related to the Sponsor, Investigator, or Study Site

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03124381). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.