Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 in Moderate to Severe Acne

Phase 2

Completed

Conditions: Acne Vulgaris

Interventions: Drug: LEO43204
Drug: Placebo

Registration Number: NCT02575950

Lead Sponsor: LEO Pharma

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 59

Inclusion Criteria

Subjects should be diagnosed with acne vulgaris of the face
Fitzpatrick skin types I-III (due to lack of safety data for the investigational product in darker skin types)
Disease severity and total lesion count should be similar in both TAs
Disease severity grade as moderate to severe according to the investigator's global assessment (grade 3-4)
Age 18 to 35 years incl.
Male or female
Female Subjects must be of either non-childbearing potential or child-bearing potential with a confirmed negative pregnancy test

Exclusion Criteria

Subjects with nodulocystic acne, acne conglobata, acne fulminans, secondary acne (e.g. chlor-acne, drug-induced acne)
Subjects with previous history of keloid formation or post-inflammatory hyperpigmentation
Systemic retinoids within 12 month or systemic antibiotics within 1 month before Day 1
Topical retinoids within 3 months before Day 1 or other topical treatments and/or medicated products and cosmetics that in the opinion of the investigator may influence the subjects acne vulgaris (including soaps containing antibacterial agents such as benzoyl peroxide, keratinolytic agents such as salicylic acid, skin fresheners/astringents or aftershave products) within 1 month before Day 1

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEO43204 0,018%	LEO43204	Experimental drug
Vehicle	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Total Lesion Count (Inflammatory and Non-inflammatory)	At Week 12 (Day 84)	Total lesion count (inflammatory and non-inflammatory) in acne lesion areas.

Secondary Outcome Measures

Name	Time	Method
Inflammatory Lesion Count	At Week 12 (Day 84)	Count of inflammatory lesions in acne lesion areas
Non-inflammatory Lesion Count	At Week 12 (Day 84)	Count of non-inflammatory lesions in acne lesion areas
Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area	At Week 12 (Day 84)	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
Composite Local Skin Response (LSR) Score at All Visits	At baseline (Day 1), Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12	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.
Participant's Component LSR Score: Erosion/Ulceration	At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12	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
Participant's Component LSR Score: Crusting	At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12	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
Participant's Component LSR Score: Erythema	At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12	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
Number of Participants With Occurrence of Unacceptable LSR Scores or Unacceptable Safety and Tolerability Events at All Visits	At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12	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
Participant's Component LSR Score: Flaking/Scaling	At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12	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
Participant's Component LSR Score: Swelling	At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12	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
Participant's Component LSR Score: Vesiculation/Pustulation	At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12	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