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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
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

Brief Summary:
An exploratory Phase 2, single, centre, prospective, randomized, placebo-controlled, double-blinded, split-face (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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 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) in the treatment area for LEO 43204 gel and vehicle gel at Week 12 [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Inflammatory lesion count in the treatment area for LEO 43204 gel and vehicle gel at Week 12 [ Time Frame: 12 weeks ]
  2. Non-inflammatory lesion count in the treatment area for LEO 43204 gel and vehicle gel at Week 12 [ Time Frame: 12 weeks ]
  3. Investigator's Global Assessment of the treatment area at Week 12 [ Time Frame: 12 weeks ]
  4. Composite and component LSR score at all visits [ Time Frame: 12 weeks ]
  5. Occurrence of unacceptable LSR scores or unacceptable safety and tolerability events at all visits [ Time Frame: 12 weeks ]


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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
United States, California
Torrance Clinical Research Institute Inc.
Lomita, California, United States, 90717
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Hala Koudsi, MD Torrance Clinical Research Institute Inc.

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
Last Update Posted: January 19, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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