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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

Tracking Information
First Submitted Date  ICMJE October 13, 2015
First Posted Date  ICMJE October 15, 2015
Results First Submitted Date  ICMJE December 27, 2018
Results First Posted Date  ICMJE February 28, 2019
Last Update Posted Date February 28, 2019
Study Start Date  ICMJE June 2016
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 14, 2015)
  • Count of total (inflammatory and non-inflammatory) lesions at Week 12 [ Time Frame: 12 weeks ]
  • Investigator's Global Assessment of the treatment area at Week 12 [ Time Frame: 12 weeks ]
Change History Complete list of historical versions of study NCT02575950 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2019)
  • Inflammatory Lesion Count [ Time Frame: At Week 12 (Day 84) ]
    Count of inflammatory lesions in acne lesion areas
  • Non-inflammatory Lesion Count [ Time Frame: 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 [ 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
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 14, 2015)
  • Count of inflammatory lesions at Week 12 [ Time Frame: 12 weeks ]
  • Count of non-inflammatory lesions at Week 12 [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 in Moderate to Severe Acne
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE
  • Drug: LEO43204
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: LEO43204 0,018%
    Experimental drug
    Intervention: Drug: LEO43204
  • Placebo Comparator: Vehicle
    Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 26, 2019)
59
Original Estimated Enrollment  ICMJE
 (submitted: October 14, 2015)
40
Actual Study Completion Date  ICMJE April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02575950
Other Study ID Numbers  ICMJE EXP-1223
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party LEO Pharma
Study Sponsor  ICMJE LEO Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hala Koudsi, MD Torrance Clinical Research Institute Inc.
PRS Account LEO Pharma
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP