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Completed

NCT Number: NCT02575950

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Torrance Clinical Research Institute Inc.

Lomita, California, 90717, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LEO43204

Drug

Placebo

Drug

Primary outcomes

  1. Total Lesion Count (Inflammatory and Non-inflammatory)

    Time frame: At Week 12 (Day 84)

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

Secondary outcomes

  1. Inflammatory Lesion Count

    Time frame: At Week 12 (Day 84)

    Count of inflammatory lesions in acne lesion areas

  2. Non-inflammatory Lesion Count

    Time frame: At Week 12 (Day 84)

    Count of non-inflammatory lesions in acne lesion areas

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

    Time frame: 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

    • 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

  4. Composite Local Skin Response (LSR) Score at All Visits

    Time frame: 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.

  5. Participant's Component LSR Score: Erosion/Ulceration

    Time frame: 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

    • Lesion specific erosion
    • Erosion extending beyond individual lesions
    • Erosion >50%
    • Black eschar or ulceration

  6. Participant's Component LSR Score: Crusting

    Time frame: 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

    • isolated crusting
    • Crusting<50%
    • Crusting>50%
    • Crusting extending outside treatment area

  7. Participant's Component LSR Score: Erythema

    Time frame: 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

    • slightly pink <50%
    • Pink or light red >50%
    • Red,restricted to treatment area
    • Red extending outside treatment area

  8. Participant's Component LSR Score: Flaking/Scaling

    Time frame: 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

    • Isolated scale, specific to lesion
    • Scale<50%
    • Scale>50%
    • Scaling extending outside treatment area

  9. Participant's Component LSR Score: Swelling

    Time frame: 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

    • Slight, lesion specific oedema
    • Palpable oedema extending beyond individual lesions
    • Confluent and/or visible oedema
    • Marked swelling extending outside treatment area

  10. Participant's Component LSR Score: Vesiculation/Pustulation

    Time frame: 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

    • 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

  11. Number of Participants With Occurrence of Unacceptable LSR Scores or Unacceptable Safety and Tolerability Events at All Visits

    Time frame: 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:

    • 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

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 15, 2015
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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