A Randomized, Evaluator-Blinded, Bilateral Comparison Study of Two Topicals in the Treatment of Subjects With Acne Vulgaris

Absolute Change From Baseline to Week 6 in Inflammatory Lesion Count

时间窗: Day 1/ Baseline and Week 6

Inflammatory lesion count (ILC) included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material).

Number of Participants With 0 to 4 Investigator's Global Assessment Score at Week 6

时间窗: At Week 6

Severity of acne vulgaris was assessed by Investigator Global Assessment (IGA). The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. Low score represented best outcome and higher score value indicated worst outcome.

Number of Participants Achieving Investigator's Global Assessments Treatment Success at Week 6

时间窗: At Week 6

Severity of acne vulgaris was assessed by IGA. The IGA score is a static evaluation of the overall severity or "average" degree of severity of a participant's disease by the Blinded Evaluator taking into account all of the participant's facial acne lesions as the participant appears on the day of the evaluation. Overall severity of acne was assessed using a five-point scale where 0=Clear, 1=Almost Clear, 2=Mild, 3=Moderate, and 4=Severe. The IGA treatment "success" was defined as at least a two-point improvement in IGA score relative to Baseline.

Percentage Change From Baseline to Week 6 in Inflammatory Lesion Count

时间窗: Day 1/ Baseline and Week 6

The ILC included papules (raised inflammatory lesions with no visible purulent material) and pustules (raised inflammatory lesions with visible purulent material).

Absolute Change From Baseline to Week 6 in Non-Inflammatory Lesion Count

时间窗: Day 1/ Baseline and Week 6

The non-inflammatory lesion count (NILC) included open and closed comedones.

Percentage Change From Baseline to Week 6 in Non-Inflammatory Lesion Count

时间窗: Day 1/ Baseline and Week 6

The NILC included open and closed comedones.

Change in Sebum Percentage Relative to Baseline Versus Weeks 2, 4, 6 and 7

时间窗: Day 1/Baseline and Weeks 2, 4, 6 and 7

Sebum measurement was conducted on the right and left side of the face. The sebum measurement represented the sebum score of saturation of the film and had a range of 0 to 99, where 99 equated to very oily skin.

Change in Transepidermal Water Loss Relative to Baseline Versus Weeks 2, 4, 6 and 7

时间窗: Day 1/Baseline and Weeks 2, 4, 6 and 7

Transepidermal Water Loss (TEWL) was conducted on the right and left side of the face.

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

时间窗: Day 1 until Week 7 (End of Study) and Unscheduled Visit

An adverse event is any untoward medical occurrence associated with the use of a drug in participants, whether or not considered drug related.

Number of Participants Having Local Skin Reactions With Improved/Same Versus Worsened Severities Compared to Baseline

时间窗: Day 1 until Week 7 (End of Study) or Unscheduled Visit

The local skin reactions (LSRs) included erythema, edema, scaling/dryness, burning/stinging, pruritus, erosion, and pain) were assessed. Erythema, edema, scaling/dryness, and erosion were assessed by the investigator and burning/stinging, pain, and pruritus were assessed by the participant. Assessments was made using a 4-point ordinal scale where 0=absent, 1=mild (slight, barely perceptible), 2=moderate (distinct presence), and 3=severe (marked, intense). Here, lower point represented no reaction and higher points represented severe reactions.The LSRs were assessed both before and 15 minutes following test article application.