The combined bacteriostatic and immunomodulatory effects of erythromycin and clindamycin will be explored. Treatment effects will be extensively characterized by conventional methods including lesion counts, global assessment scales and visual grading as well as state-of-the-art methodology, including multi-modal photo analysis, perfusion by laser speckle contrast imaging, analysis of local skin surface, biopsy biomarkers and skin microbiota. This extensive response profiling, combined with the mechanistic insights from concurrent in vitro and in vivo studies in healthy volunteer challenges, will increase the understanding of erythromycin's and clindamycin's effects in acne vulgaris.
Healthy male and female subjects, 18 to 45 years of age. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AV following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
Mild to moderate inflammatory acne vulgaris on the face, ≥5 inflammatory lesions (papules and/or pustules), present at screening and baseline visit
A maximum of 5 nodules present at screening and baseline visit
Inflammatory acne present for at least 6 months
Severe acne where systemic treatment is needed
Use of any topical (anti-acne) medication (prescription or OTC) within 2 weeks prior to baseline
Use of any oral/systemic treatment for acne, including oral antibiotics, excluding OAC, within 4 weeks prior to baseline
Use of systemic isotretinoin within 6 months prior to baseline
Parallel
Erythromycin 4% topical gel formulation
DrugErythromycin 4% topical gel formulation, BID, 4 weeks
Clindamycin 1% topical lotion formulation
DrugClindamycin 1% topical lotion formulation, BID, 4 weeks
70% topical ethanol solution
Drug70% topical ethanol solution, BID, 4 weeks
Efficacy endpoint 1 - Change in lesion count
The inflammatory lesions include papules pustules and nodules/cysts. At screening and every study visit, the evaluator will count the inflammatory lesions separately by area on the face (forehead, right cheek, left cheek, chin and nose). All lesion counts during the treatment and follow-up period will be performed by a treatment-blinded evaluator
Efficacy endpoint 2 - Change in investigator Global Assessment acne (IGA)
Acne severity will be assessed at screening and every study visit by the Investigator Global Assessment for facial acne (clear, almost clear, mild, moderate, severe, very severe). This will be done by a treatment blinded evaluator.
Change in Patient Reported Outcome (PRO)
Pre-dose and at EOT patients will be asked how they would rate their acne that day using the subjective Patient Global Assessment (clear, almost clear, mild, moderate, severe, very severe)
Pharmacodynamic endpoints 1 - Change in Standardized facial photography by Canfield Visia and via selfie app
A standardized set of 3 facial photos (front, left, right) will be taken every study visit by Canfield Visia CR. Furthermore, patients will take daily selfies with a validated mobile app.
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Centre for Human Drug Research, Netherlands
Lead sponsor
Maruho Co., Ltd.
Collaborator
