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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

LEO43204

Placebo

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Torrance Clinical Research Institute Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LEO43204 0,018%

Vehicle

Arm Description

Experimental drug

Placebo

Outcomes

Primary Outcome Measures

Total Lesion Count (Inflammatory and Non-inflammatory)

Total lesion count (inflammatory and non-inflammatory) in acne lesion areas.

Secondary Outcome Measures

Inflammatory Lesion Count

Count of inflammatory lesions in acne lesion areas

Non-inflammatory Lesion Count

Count of non-inflammatory lesions in acne lesion areas

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 Almost clear; rare non-inflammatory lesions with no more than one small inflammatory lesion Mild severity; greater than Grade 1; some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 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 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

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

The Erosion/Ulceration score was determined according to the 5 point scale below. 0=not present Lesion specific erosion Erosion extending beyond individual lesions Erosion >50% Black eschar or ulceration

Participant's Component LSR Score: Crusting

The crusting score was determined according to the 5 point scale below. 0=not present isolated crusting Crusting<50% Crusting>50% Crusting extending outside treatment area

Participant's Component LSR Score: Erythema

The erythema score was determined according to the 5 point scale below. Erythema 0=not present slightly pink <50% Pink or light red >50% Red,restricted to treatment area Red extending outside treatment area

Participant's Component LSR Score: Flaking/Scaling

The flaking/scaling score was determined according to the 5 point scale below. 0=not present Isolated scale, specific to lesion Scale<50% Scale>50% Scaling extending outside treatment area

Participant's Component LSR Score: Swelling

The swelling score was determined according to the 5 point scale below. 0=Not present Slight, lesion specific oedema Palpable oedema extending beyond individual lesions Confluent and/or visible oedema Marked swelling extending outside treatment area

Participant's Component LSR Score: Vesiculation/Pustulation

The vesiculation/postulation score was determined according to the 5 point scale below. 0=not present vesicles only Transudate or pustulates with or without vesicles <50% Transudate or pustulates, with or without vesicles >50% Transudate or pustulates, with or without vesicles extending outside treatment area 4=Marked swelling extending outside treatment area

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: Clinically relevant signs or symptoms that in the opinion of the investigator were deemed unacceptable. 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

Full Information

NCT ID

NCT02575950

First Posted

October 13, 2015

Last Updated

February 26, 2019

Sponsor

LEO Pharma

1. Study Identification

Unique Protocol Identification Number

NCT02575950

Brief Title

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

Official Title

Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 Applied in a Split-face (Left/Right) Topical Design in Adults With Moderate to Severe Acne

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

June 2016 (undefined)

Primary Completion Date

April 2017 (Actual)

Study Completion Date

April 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

LEO Pharma

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LEO43204 0,018%

Arm Type

Experimental

Arm Description

Experimental drug

Arm Title

Vehicle

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

LEO43204

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Total Lesion Count (Inflammatory and Non-inflammatory)

Description

Total lesion count (inflammatory and non-inflammatory) in acne lesion areas.

Time Frame

At Week 12 (Day 84)

Secondary Outcome Measure Information:

Title

Inflammatory Lesion Count

Description

Count of inflammatory lesions in acne lesion areas

Time Frame

At Week 12 (Day 84)

Title

Non-inflammatory Lesion Count

Description

Count of non-inflammatory lesions in acne lesion areas

Time Frame

At Week 12 (Day 84)

Title

Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area

Description

The IGA score was determined according to the 5 point scale below. 0=Clear skin with no inflammatory and non-inflammatory lesions Almost clear; rare non-inflammatory lesions with no more than one small inflammatory lesion Mild severity; greater than Grade 1; some non-inflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) 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 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)

Title

Composite Local Skin Response (LSR) Score at All Visits

Description

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.

Time Frame

At baseline (Day 1), Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12

Title

Participant's Component LSR Score: Erosion/Ulceration

Description

The Erosion/Ulceration score was determined according to the 5 point scale below. 0=not present Lesion specific erosion Erosion extending beyond individual lesions Erosion >50% Black eschar or ulceration

Time Frame