Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients … (NCT01461655) | Clinical Trial Compass
CompletedPhase 2
Efficacy and the Tolerability of the Sequential Application of Two Marketed Products in Patients With Acne Vulgaris
France40 participantsStarted 2011-11
Plain-language 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
Who can participate
Age range18 Years – 35 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 contraceptive…
What they're measuring
1
Percentage Change in Inflammatory Lesions From Baseline to End of Treatment