Actively Recruiting
Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients
Led by Centre for Human Drug Research, Netherlands · Updated on 2019-03-20
30
Participants Needed
1
Research Sites
88 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
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.
CONDITIONS
Official Title
Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males and females aged 18 to 45 years
- Mild to moderate inflammatory acne vulgaris on the face with 5 or more 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 give written informed consent and follow study restrictions
- Willing to undergo 2x2mm facial skin punch biopsies
You will not qualify if you...
- Severe acne requiring systemic treatment
- Use of any topical anti-acne medication within 2 weeks before baseline
- Use of any oral or systemic acne treatment, including oral antibiotics, within 4 weeks before baseline
- Use of systemic isotretinoin within 6 months before baseline
- History of pathological scar formation (keloid or hypertrophic scar)
- Known allergy to erythromycin, clindamycin, or related drugs or their ingredients
- Known contact dermatitis to any product
- Tanning from sunbathing, excessive sun exposure, or tanning booth within 3 weeks before enrollment
- Participation in another investigational drug or device study within 3 months before screening or more than 4 times a year
- Loss or donation of over 500 mL of blood within 3 months (males) or 4 months (females) before screening
- Pregnant, breastfeeding, or planning pregnancy
AI-Screening
AI-Powered Screening
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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
CONTACT
D
Diana Noort
CONTACT
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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