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

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ClinicalTrials.gov Identifier: NCT02575950
Recruitment Status : Completed
First Posted : October 15, 2015
Results First Posted : February 28, 2019
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: LEO43204 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : June 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: LEO43204 0,018%
Experimental drug
Drug: LEO43204
Placebo Comparator: Vehicle
Placebo
Drug: Placebo



Primary Outcome Measures :
  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 Outcome Measures :
  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

    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

  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

    1. Lesion specific erosion
    2. Erosion extending beyond individual lesions
    3. Erosion >50%
    4. 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

    1. isolated crusting
    2. Crusting<50%
    3. Crusting>50%
    4. 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

    1. slightly pink <50%
    2. Pink or light red >50%
    3. Red,restricted to treatment area
    4. 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

    1. Isolated scale, specific to lesion
    2. Scale<50%
    3. Scale>50%
    4. 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

    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

  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

    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


  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:

    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



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02575950


Locations
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United States, California
Torrance Clinical Research Institute Inc.
Lomita, California, United States, 90717
Sponsors and Collaborators
LEO Pharma
Investigators
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Principal Investigator: Hala Koudsi, MD Torrance Clinical Research Institute Inc.
  Study Documents (Full-Text)

Documents provided by LEO Pharma:
Study Protocol  [PDF] September 15, 2016
Statistical Analysis Plan  [PDF] May 19, 2017


Additional Information:
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02575950     History of Changes
Other Study ID Numbers: EXP-1223
First Posted: October 15, 2015    Key Record Dates
Results First Posted: February 28, 2019
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases