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

LEO Pharma

Status and phase: Completed; Phase 2

Conditions: Acne Vulgaris

Treatments: Drug: Placebo; Drug: LEO43204

Study type: Interventional

Funder types: Industry

Identifiers

NCT02575950

EXP-1223

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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59 participants in 2 patient groups, including a placebo group

LEO43204 0,018%

Experimental group

Description:

Experimental drug

Treatment:

Drug: LEO43204

Vehicle

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo