Clinical Assessments. Clinical grading by visual assessment was completed by a qualified investigator. Lesions counts using a protocol-designated quadrant diagram were completed at baseline and weeks 4, 8, and 12, including inflammatory lesions (papules and pustules), non-inflammatory lesions (open and closed comedones), and total AV lesions (inflammatory lesions + noninflammatory lesions). IGA was completed at baseline and at weeks 4, 8, and 12 using the aforementioned 5-point scale (0 = none, 4 = severe) (Table 1).
Clinical Photography. High-resolution facial images were captured with consent at baseline and weeks 4, 8, and 12 using the Visia-CR (Canfield) or Mark-Vu (All States MED) systems.
Tolerability Assessments. Objective assessment by the investigator of erythema, edema, dryness, and peeling was completed at baseline and weeks 4, and 12 using a 4-point scale (0 = none, 3 = severe).
Subjective assessment by the participants of burning, stinging, and itching was completed at baseline and at weeks 4, 8, and 12 using a 4-point scale (0 = none, 3 = severe) (Figure 1).
Subject Self-Perception Questionnaires (SPQ). Product attributes and efficacy were evaluated by participants at weeks 1, 4, 8, and 12 using a 5-point scale (1 = strongly agree, 5 = strongly disagree). Additional participant comments on product recommendations, purchase intent, and testimonials were captured at end of study (Figure 1).
Clinical Photography. High-resolution facial images were captured with consent at baseline and weeks 4, 8, and 12 using the Visia-CR (Canfield) or Mark-Vu (All States MED) systems.
Tolerability Assessments. Objective assessment by the investigator of erythema, edema, dryness, and peeling was completed at baseline and weeks 4, and 12 using a 4-point scale (0 = none, 3 = severe).
Subjective assessment by the participants of burning, stinging, and itching was completed at baseline and at weeks 4, 8, and 12 using a 4-point scale (0 = none, 3 = severe) (Figure 1).
Subject Self-Perception Questionnaires (SPQ). Product attributes and efficacy were evaluated by participants at weeks 1, 4, 8, and 12 using a 5-point scale (1 = strongly agree, 5 = strongly disagree). Additional participant comments on product recommendations, purchase intent, and testimonials were captured at end of study (Figure 1).
STUDY DEMOGRAPHICS
The participant distribution and demographics are depicted in Table 3. Of the 45 adult participants that were enrolled, 44 completed the study, with a mean age of 38.2 years. Enrollment was purposefully designed to achieve at least 80% female participants and to be inclusive of all Fitzpatrick skin types, races, and ethnicities.
