Clinical trial NCT02575950: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acne Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-10-15
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Total Lesion Count (Inflammatory and Non-inflammatory)
timeFrame: At Week 12 (Day 84)
Secondary outcomes:
measure: Inflammatory Lesion Count
timeFrame: At Week 12 (Day 84)
measure: Non-inflammatory Lesion Count
timeFrame: At Week 12 (Day 84)
measure: Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area
timeFrame: At Week 12 (Day 84)
measure: Composite Local Skin Response (LSR) Score at All Visits
timeFrame: At baseline (Day 1), Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
measure: Participant's Component LSR Score: Erosion/Ulceration
timeFrame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
measure: Participant's Component LSR Score: Crusting
timeFrame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
measure: Participant's Component LSR Score: Erythema
timeFrame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
measure: Participant's Component LSR Score: Flaking/Scaling
timeFrame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
measure: Participant's Component LSR Score: Swelling
timeFrame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
measure: Participant's Component LSR Score: Vesiculation/Pustulation
timeFrame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
measure: Number of Participants With Occurrence of Unacceptable LSR Scores or Unacceptable Safety and Tolerability Events at All Visits
timeFrame: At Day 1, Day 2, Day 3, Day 4, Day 8, Week 2, Week 4, Week 8 and Week 12
Other outcomes:
Locations:
city: Lomita
country: United States
facility: Torrance Clinical Research Institute Inc.
state: California
Study officials:
affiliation: Torrance Clinical Research Institute Inc.
name: Hala Koudsi, MD
role: PRINCIPAL_INVESTIGATOR
References: