An exploratory Phase 2, single, centre, prospective, randomized, placebo-controlled, double-blinded, split-pace (left/right) design trial to evaluate the efficacy and tolerability of LEO 43204 in adults with moderate to severe acne.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
59
Torrance Clinical Research Institute Inc.
Lomita, California, United States
Total Lesion Count (Inflammatory and Non-inflammatory)
Total lesion count (inflammatory and non-inflammatory) in acne lesion areas.
Time frame: At Week 12 (Day 84)
Inflammatory Lesion Count
Count of inflammatory lesions in acne lesion areas
Time frame: At Week 12 (Day 84)
Non-inflammatory Lesion Count
Count of non-inflammatory lesions in acne lesion areas
Time frame: At Week 12 (Day 84)
Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area
The IGA score was determined according to the 5 point scale below. 0=Clear skin with no inflammatory and non-inflammatory lesions 1. Almost clear; rare non-inflammatory lesions with no more than one small inflammatory lesion 2. Mild severity; greater than Grade 1; some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 3. Moderate severity; greater than Grade 2; up to many non-inflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesions 4. Severe; greater than Grade 3; up to many non-inflammatory and inflammatory lesions, but no more than a few nodular lesions
Time frame: At Week 12 (Day 84)
Composite Local Skin Response (LSR) Score at All Visits
The Local Skin Responses consists of the following 6 components: erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR component is given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity. The composite LSR score (0-24) is the sum of the scores graded from 0 to 4 on all six individual LSR categories. Please see following outcome measure descriptions on the grading scale for the individual components: * Erosion/ulceration: 6. Secondary outcome measure * Crusting: 7. Secondary outcome measure. * Erythema: 8. Secondary outcome measure. * Flaking/scaling: 9. Secondary outcome measure. * Swelling: 10. Secondary outcome measure. * Vesiculation/pustulation: 11. Secondary outcome measure.
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Time frame: At baseline (Day 1), Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Participant's Component LSR Score: Erosion/Ulceration
The Erosion/Ulceration score was determined according to the 5 point scale below. 0=not present 1. Lesion specific erosion 2. Erosion extending beyond individual lesions 3. Erosion \>50% 4. Black eschar or ulceration
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Participant's Component LSR Score: Crusting
The crusting score was determined according to the 5 point scale below. 0=not present 1. isolated crusting 2. Crusting\<50% 3. Crusting\>50% 4. Crusting extending outside treatment area
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Participant's Component LSR Score: Erythema
The erythema score was determined according to the 5 point scale below. Erythema 0=not present 1. slightly pink \<50% 2. Pink or light red \>50% 3. Red,restricted to treatment area 4. Red extending outside treatment area
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Participant's Component LSR Score: Flaking/Scaling
The flaking/scaling score was determined according to the 5 point scale below. 0=not present 1. Isolated scale, specific to lesion 2. Scale\<50% 3. Scale\>50% 4. Scaling extending outside treatment area
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Participant's Component LSR Score: Swelling
The swelling score was determined according to the 5 point scale below. 0=Not present 1. Slight, lesion specific oedema 2. Palpable oedema extending beyond individual lesions 3. Confluent and/or visible oedema 4. Marked swelling extending outside treatment area
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Participant's Component LSR Score: Vesiculation/Pustulation
The vesiculation/postulation score was determined according to the 5 point scale below. 0=not present 1. vesicles only 2. Transudate or pustulates with or without vesicles \<50% 3. Transudate or pustulates, with or without vesicles \>50% 4. Transudate or pustulates, with or without vesicles extending outside treatment area 4=Marked swelling extending outside treatment area
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Number of Participants With Occurrence of Unacceptable LSR Scores or Unacceptable Safety and Tolerability Events at All Visits
Unacceptable LSRs, safety and tolerability in an individual participant were defined as: 1. Clinically relevant signs or symptoms that in the opinion of the investigator were deemed unacceptable. 2. Occurrence of LSRs as specified below: One of the following * Grade 4 crusting * Grade 4 erosion/ulceration * Grade 4 vesiculation/pustulation extending significantly outside treatment areas Two of the following * Grade 4 erythema * Grade 3 crusting * Grade 4 swelling extending significantly outside treatment areas * Grade 3 erosion/ulceration * Grade 3 vesiculation/pustulation
Time frame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12