Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients

Официальное название

A Randomized, Placebo-controlled, Evaluator-blinded, Study to Assess the Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Patients With Inflammatory Facial Acne

Обзор

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.

Вмешательства

• Препарат Erythromycin 4% topical gel formulation
  Erythromycin 4% topical gel formulation, BID, 4 weeks
• Препарат Clindamycin 1% topical lotion formulation
  Clindamycin 1% topical lotion formulation, BID, 4 weeks
• Препарат 70% topical ethanol solution
  70% topical ethanol solution, BID, 4 weeks

Первичные конечные точки

• Efficacy endpoint 1 - Change in lesion count [Срок оценки: Day 0, day 7, day 14, day 21, day 28 and day 42]
• Efficacy endpoint 2 - Change in investigator Global Assessment acne (IGA) [Срок оценки: Day 0, day 7, day 14, day 21, day 28 and day 42]
• Change in Patient Reported Outcome (PRO) [Срок оценки: Day 0 and day 28]
• Pharmacodynamic endpoints 1 - Change in Standardized facial photography by Canfield Visia and via selfie app [Срок оценки: Day 0, day 7, day 14, day 21, day 28 and day 42]
• Pharmacodynamic endpoints 2 - Change in Sebum measurements by Sebumeter® [Срок оценки: Day 0, day 7, day 14, day 21, day 28 and day 42]
• Pharmacodynamic endpoints 3 - Change in Perfusion by Laser Speckle Contrast Imaging (LSCI) [Срок оценки: Day 0, day 7, day 14, day 21, day 28 and day 42]
• Pharmacodynamic endpoints 4 - Change in Morphology by Optical Coherence Tomography (OCT) [Срок оценки: Day 0, day 7, day 14, day 21, day 28 and day 42]
• Pharmacodynamic endpoints 5 - Change in Local skin biopsy biomarkers [Срок оценки: Day 0 and day 28]
• Pharmacodynamic endpoints 6 - Change in Local skin surface biomarkers by TAP [Срок оценки: Day 0, day 7, day 14, day 21, day 28 and day 42]
• Pharmacodynamic endpoints 7 - Change in skin microbiota [Срок оценки: Day 0, day 7, day 14, day 21, day 28 and day 42]

Критерии участия

Критерии включения

• 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
• Fitzpatrick skin type I-II (Caucasian)
• Able and willing to give written informed consent and to comply with the study restrictions.
• Willing to comply with 2x2mm facial skin punch biopsies

Критерии исключения

• 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
• History of pathological scar formation (keloid, hypertrophic scar)
• Known hypersensitivity to erythromycin or clindamycin, drugs of the same class, or any of their excipients.
• Known contact dermatitis reaction to any product
• Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment.
• Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
• Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening
• Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Нидерланды · 1 центр

• Centre for Human Drug Research — Leiden

Идентификаторы

NCT: NCT03883269 · CHDR1732

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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