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



Status:Completed
Conditions:Acne, Acne, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 35
Updated:3/2/2019
Start Date:June 2016
End Date:April 2017

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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

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.


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
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