Phase 2
Completed N=40
Explorative Trial Evaluating the Efficacy and Tolerability of LEO43204 in Moderate to Severe Acne
Source: ClinicalTrials.gov NCT02575950 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2019
Primary outcomePrimary: Total Lesion Count (Inflammatory and Non-inflammatory) — 23.57; 32.90 Lesions — p=<.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Lesion Count (Inflammatory and Non-inflammatory) |
23.57; 32.90 | <.001 sig |
| SECONDARY Inflammatory Lesion Count |
3.81; 5.91 | — |
| SECONDARY Non-inflammatory Lesion Count |
20.03; 25.31 | — |
| SECONDARY Number of Participants Stratified by Investigator's Global Assessment (IGA) of the Treatment Area |
3; 2; 19; 5; 9; 24 | — |
| SECONDARY Composite Local Skin Response (LSR) Score at All Visits |
0.13; 0.00; 1.34; 0.41; 3.03; 0.90 | — |
| SECONDARY Participant's Component LSR Score: Erosion/Ulceration |
38; 39; 0; 0; 0; 0 | — |
| SECONDARY Participant's Component LSR Score: Crusting |
37; 39; 0; 0; 1; 0 | — |
| SECONDARY Participant's Component LSR Score: Erythema |
38; 39; 0; 0; 0; 0 | — |
| SECONDARY Participant's Component LSR Score: Flaking/Scaling |
37; 39; 0; 0; 0; 0 | — |
| SECONDARY Participant's Component LSR Score: Swelling |
38; 39; 0; 0; 0; 0 | — |
| SECONDARY Participant's Component LSR Score: Vesiculation/Pustulation |
38; 39; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Occurrence of Unacceptable LSR Scores or Unacceptable Safety and Tolerability Events at All Visits |
0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT02575950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.