Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: marketed topical retinoid; marketed topical NSAID; vehicle gel; marketed topical retinoid
Intervention description: once daily application, 4 weeks; once daily application, 4 weeks; once daily application, 4 weeks; once daily application, 4 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 35 Years
Healthy volunteers: No

Summary:

      The aim of this proof of principle study is to evaluate efficacy and safety of the sequential
      application of two marketed products for the treatment of acne vulgaris, using the Split-Face
      model
    

Eligibility criteria:

        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