PIVOTAL Studies 1 & 2
FIRST LARGE-SCALE CLINICAL TRIALS.1
PIVOTAL Studies 1 & 2 were the first large-scale, randomized, Phase 3 clinical trials to simultaneously evaluate a topical therapy for the treatment of both moderate facial and truncal acne vulgaris.1
Study Design
2,420
PATIENTS RANDOMIZED 1:1
From sites across US, Canada, Europe, and Russia
Mean age: 19 years (9-58 years); AKLIEF Cream once daily
AKLIEF Cream
n=1,214
VEHICLE
n=1,206
PIVOTAL Studies 1 & 2
PRIMARY ENDPOINTS:
FACE1
- Success rate: Percentage of subjects with IGA* of clear (0) or almost clear (1) and at least a 2-grade improvement from baseline to Week 12
- Absolute change in facial inflammatory and non-inflammatory lesion count from baseline to Week 12
*The definitions of severity for the 5-point IGA and PGA scales were the same: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe).
IGA=Investigator’s Global Assessment.
PIVOTAL Studies 1 & 2
SECONDARY ENDPOINTS:
TRUNK1
- Success rate: Percentage of subjects with PGA* of clear (0) or almost clear (1) and at least a 2-grade improvement from baseline to Week 12
- Absolute change in truncal inflammatory and
non-inflammatory lesion count from baseline to Week 12
*The definitions of severity for the 5-point IGA and PGA scales were the same: 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe).
PGA=Physician’s Global Assessment.
PIVOTAL Studies 1 & 2
SAFETY ENDPOINTS1
- Incidence of adverse events
- Local tolerability (erythema, scaling, dryness, stinging, burning)
AKLIEF Cream
PROVEN TO REDUCE INFLAMMATORY LESIONS OF ACNE.1
SIGNIFICANT REDUCTION IN FACIAL INFLAMMATORY LESIONS AT WEEK 12 VS VEHICLE.1
54.4%
REDUCTION IN INFLAMMATORY LESIONS VS BASELINE AT 12 WEEKS.1
VS 44.8% REDUCTION WITH VEHICLE; P<0.001.
In AKLIEF Cream PIVOTAL Study 1, significant improvement seen as early as Week 2.1
SIGNIFICANT REDUCTION IN FACIAL INFLAMMATORY LESIONS AT WEEK 12 VS VEHICLE.1
66.2%
REDUCTION IN INFLAMMATORY LESIONS VS BASELINE AT 12 WEEKS.1
VS 51.2% REDUCTION WITH VEHICLE; P<0.001.
In AKLIEF Cream PIVOTAL Study 2, significant improvement seen as early as Week 2.1
AKLIEF Cream
PROVEN TO REDUCE INFLAMMATORY LESIONS OF ACNE.1
SIGNIFICANT REDUCTION IN TRUNCAL INFLAMMATORY LESIONS AT WEEK 12 VS VEHICLE.1
57.4%
REDUCTION IN INFLAMMATORY LESIONS VS BASELINE AT 12 WEEKS.1
VS 50% REDUCTION WITH VEHICLE; P<0.001.
In AKLIEF Cream PIVOTAL Study 1, significant improvement seen as early as Week 4.1
SIGNIFICANT REDUCTION IN TRUNCAL INFLAMMATORY LESIONS AT WEEK 12 VS VEHICLE.1
65.4%
REDUCTION IN INFLAMMATORY LESIONS VS BASELINE AT 12 WEEKS.1
VS 51.1% REDUCTION WITH VEHICLE; P<0.001.
In AKLIEF Cream PIVOTAL Study 2, significant improvement seen as early as Week 2.1
SAFE AND WELL-TOLERATED ON BOTH THE FACE AND TRUNK.1
PIVOTAL STUDY 1: TOLERABILITY SIGNS AND SYMPTOMS*
Local irritation was transient, peaking at Week 1 on the face and Weeks 2-4 on the trunk and decreased thereafter.1
Most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus (itching), and sunburn.
*Local tolerability signs and symptoms were evaluated on a 4-point severity scale: 0 (none), 1 (mild), 2 (moderate), and 3 (severe) from baseline to Week 12.
SAFE AND WELL-TOLERATED ON BOTH THE FACE AND TRUNK.1
PIVOTAL STUDY 1: TOLERABILITY SIGNS AND SYMPTOMS*
Local irritation was transient, peaking at Week 1 on the face and Weeks 2-4 on the trunk and decreased thereafter.1
Most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus (itching), and sunburn.
*Local tolerability signs and symptoms were evaluated on a 4-point severity scale: 0 (none), 1 (mild), 2 (moderate), and 3 (severe) from baseline to Week 12.
In a long-term safety study,
WELL-TOLERATED THROUGHOUT THE STUDY AT 1 YEAR.2*
SATISFY Study: A multicenter, open-label study of 453 patients with moderate facial and truncal acne assessing the long-term safety (primary endpoint), efficacy, and quality of life (secondary endpoints) of AKLIEF Cream over 52 weeks.
As observed with other retinoids, the majority of local adverse events occurred during the first weeks of treatment, subsiding thereafter.2
*Local tolerability signs and symptoms were evaluated on a 4-point severity scale: 0 (none), 1 (mild), 2 (moderate), and 3 (severe) from baseline to Week 52.
In a long-term safety study,
WELL-TOLERATED THROUGHOUT THE STUDY AT 1 YEAR.2*
SATISFY Study: A multicenter, open-label study of 453 patients with moderate facial and truncal acne assessing the long-term safety (primary endpoint), efficacy, and quality of life (secondary endpoints) of AKLIEF Cream over 52 weeks.
As observed with other retinoids, the majority of local adverse events occurred during the first weeks of treatment, subsiding thereafter.2
*Local tolerability signs and symptoms were evaluated on a 4-point severity scale: 0 (none), 1 (mild), 2 (moderate), and 3 (severe) from baseline to Week 52.
