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Recruiting NCT03883269

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

Phase IV Interventional Acne Vulgaris

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Erythromycin 4% topical gel formulation, Clindamycin 1% topical lotion formulation, 70% topical ethanol solution.
Who it may be relevant to
Registry conditions: Acne Vulgaris. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Centre for Human Drug Research — Leiden

Identifiers

NCT: NCT03883269 · CHDR1732

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗