Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients With Acne Vulgaris

This is an interventional treatment trial for Acne Vulgaris Read More

Inclusion Criteria:

• Subjects having understood and signed an informed consent form
• Male or female subjects who are 18 to 35 years (both included) of age presenting acne vulgaris of the face.
• A minimum of 10 inflammatory lesions (papules and pustules) on the entire face, and a minimum of 20 non-inflammatory lesions (open comedones and closed comedones) on the entire face.
• Disease severity grade as mild or moderate according to the investigator's global assessment (grade 2 or grade 3)

Exclusion Criteria:

• Females who are pregnant, of child-bearing potential and who wish to become pregnant during the study, or who are breast feeding.
• Subjects with any acne cysts or more than one nodule per hemiface.
• Subjects with acne conglobata, acne fulminans, secondary acne (e.g. chloracne, drug-induced acne), or any acne requiring systemic treatment.
• Subjects with a dark pigmentation of the skin or skin type that may, in any way, confound interpretation of the study results (skin type V or VI on Fitzpatrick scale.
• Subjects with other facial skin disorders that may interfere with study assessments.
• Subjects who will use medicated cosmetics and/or soaps (including soaps containing antibacterial agents such as benzoyl peroxide, keratolytic agents such as salicylic acid, skin fresheners/astringents or aftershave products) on the face for the duration of the study.
• Subjects with a history of actinic keratosis on the face or skin cancer.
• Use of hormonal oral contraceptives for acne control for less than 6 months prior to the randomisation.
• Subjects using one of the following systemic medication within 4 weeks before the randomisation and during the study, which could have an effect on the trial disease.
• systemic corticosteroids,
• anti-acne drugs,
• oral retinoids
• any immunosuppressive drugs.
• Subjects using systemic NSAIDs (including aspirin) within 1 week before the randomisation and during the study.
• Subjects using paracetamol within 1 week before the randomisation. Paracetamol will be allowed during the study with a maximum dose of 1g twice daily and for a maximum of 3 consecutive days
• Subjects using one of the following topical medication within 2 weeks before the randomisation and during the study, which could have an effect on the trial disease:
• anti-inflammatory drugs (e.g. topical corticosteroids, NSAIDs),
• anti-acne drugs,
• topical retinoids,
• topical antibacterial agents
• any topical immunosuppressive drugs.
• Subjects with known or suspected hypersensitivity to component(s) of the investigational products or other nonsteroidal anti- inflammatory drug NSAIDs (e.g., aspirin, diclofenac, ibuprofen, ketoprofen).
• Subjects with presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting).
• Subjects with known presence of active peptic ulcer.
• Subjects with history (during the last 10 years) or known presence of asthma.
• Subjects with history (during the last 5 years) or known presence of rhinitis or urticaria