Actively Recruiting
A Randomized, Placebo-controlled, Evaluator-blinded Study to Assess the Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Patients with Inflammatory Facial Acne
Led by Centre for Human Drug Research, Netherlands · Updated on 2019-03-20
30
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
C
Centre for Human Drug Research, Netherlands
Lead Sponsor
M
Maruho Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the combined bacteriostatic and immune system effects of two topical antibiotics, erythromycin and clindamycin, in people with mild to moderate inflammatory acne vulgaris. This Phase 4 randomized study aims to deepen understanding of how these treatments impact acne through detailed skin assessments and advanced imaging and biomarker analysis. The trial is sponsored by the Centre for Human Drug Research in the Netherlands. Participants are randomly assigned to one of three groups: erythromycin 4% topical gel, clindamycin 1% topical lotion, or a 70% topical ethanol solution as a placebo comparator. Each treatment is applied twice daily for four weeks. The study is evaluator-blinded, meaning the person assessing the outcomes does not know which treatment was given. The trial includes comprehensive skin evaluations and biopsies to assess treatment effects. During the study, participants undergo frequent assessments including lesion counts, global acne evaluations, patient-reported outcomes, standardized facial photography, sebum measurements, laser imaging of skin perfusion, optical coherence tomography, and analysis of skin and fecal microbiota. These measures are taken at multiple time points from the start through six weeks. Participants also provide facial skin biopsies at baseline and after 28 days. The total duration includes follow-up visits to monitor changes and safety.
CONDITIONS
Brief Title
Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male and female subjects aged 18 to 45 years
- Mild to moderate inflammatory acne vulgaris on the face with at least 5 inflammatory lesions
- No more than 5 nodules present at screening and baseline
- Inflammatory acne present for at least 6 months
- Fitzpatrick skin type I-II (Caucasian)
- Able and willing to provide written informed consent and comply with study restrictions
- Willing to undergo two 2x2mm facial skin punch biopsies
You will not qualify if you...
- Severe acne requiring systemic treatment
- Use of any topical acne medication within 2 weeks prior to baseline
- Use of any oral or systemic acne treatment, including antibiotics, within 4 weeks prior to baseline
- Use of systemic isotretinoin within 6 months prior to baseline
- History of pathological scar formation such as keloid or hypertrophic scars
- Known allergy to erythromycin, clindamycin, related drugs, or product ingredients
- Known contact dermatitis to any product
- Recent tanning from sunbathing, excessive sun exposure, or tanning booth within 3 weeks prior to enrollment
- Participation in another investigational drug or device study within 3 months prior to screening or more than 4 times a year
- Blood loss or donation over 500 mL within 3 months (males) or 4 months (females) prior to screening
- Pregnant, breastfeeding, positive pregnancy test, or intending to become pregnant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants apply the assigned topical medication twice daily for 4 weeks to treat inflammatory facial acne.
Visits on Day 0, 7, 14, 21, and 28 for assessments
Duration - 2 weeks
Participants are monitored for additional 2 weeks after treatment to assess treatment effects and safety.
Visit on Day 42
Trial Site Locations
Total: 1 location
1
Centre for Human Drug Research
Leiden, Netherlands, 2333 CL
Actively Recruiting
Research Team
R
Robert Rissmann, PharmD, PhD
D
Diana Noort
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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