A Phase 4 interventional study of Erythromycin 4% topical gel formulation and Clindamycin 1% topical lotion formulation in Acne Vulgaris, sponsored by Centre for Human Drug Research, Netherlands. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-03-20.
Sponsored by Centre for Human Drug Research, Netherlands · Phase 4, Interventional, and Treatment
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.
730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.
This study's planned enrollment of 30 is below the median of 69 across 628 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Centre for Human Drug Research, Netherlands is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Erythromycin 4% topical gel formulation, BID, 4 weeks
Drug: Erythromycin 4% topical gel formulation
Clindamycin 1% topical lotion formulation, BID, 4 weeks
Drug: Clindamycin 1% topical lotion formulation
70% topical ethanol solution, BID, 4 weeks
Drug: 70% topical ethanol solution
Erythromycin 4% topical gel formulation, BID, 4 weeks
Clindamycin 1% topical lotion formulation, BID, 4 weeks
70% 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
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)
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.
Time frame: Day 0, day 7, day 14, day 21, day 28 and day 42
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)
Time frame: Day 0 and day 28
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.
Time frame: Day 0, day 7, day 14, day 21, day 28 and day 42
Pharmacodynamic endpoints 2 - Change in Sebum measurements by Sebumeter®
Sebum excretion will be measured every study visit by Sebumeter®. The measurement will be repeated for 3 times and the average will be used for the analysis.
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)
Cutaneous microcirculation will be assessed using the laser speckle imager (LSCI; PeriCam PSI System, Perimed Jäfälla, Sweden). Measurements have to be performed in a temperature controlled room with a temperature around 22°C. The subject has to get accommodated to the room temperature for a minimum of 15 minutes prior to testing. After this, the speckle assessments can commence. Briefly, the subject will be resting for at least ten minutes before any measurements take place. A suitable area of the face will be identified. This area will be illuminated' by the laser and the response signal will be captured. If no suitable area can be identified, the measurement will not be performed and data will be entered as missing.
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)
Skin morphology will be assessed by optical coherence tomography at every study visit. Optical coherence tomography uses reflected light returning from skin tissue to create an image of the skin and 2 mm below the skin. The visualization can be done because different skin structures reflect light in a different way and can therefore be distinguished. Optical coherence tomography is similar to ultrasound however instead of sound it uses light refraction to visualize tissue.
Time frame: Day 0, day 7, day 14, day 21, day 28 and day 42
Pharmacodynamic endpoints 5 - Change in Local skin biopsy biomarkers
Two-millimetre punch biopsies are taken at day 0 and day 28 from a papule or pustule. Moreover, at day 0 a biopsy will be taken from nonlesional non-facial skin (upper back) as healthy control. The biopsies will be placed in RNAlater medium directly after harvest of the biopsy and stored at 4°C. Biomarker sequencing will be performed by RNA extraction and quantitative PCR will be performed for a subset of immunomodulatory biomarkers (including but not limited to IL-1b, IL-1a, TNF-a IL-6, IL-12, IL-8, IL-10, IL-17, IFN-g).
Time frame: Day 0 and day 28
Pharmacodynamic endpoints 6 - Change in Local skin surface biomarkers by TAP
Skin biomarkers will be measured pre-dose and after 7, 14, 21, 28, and 42 days by TAP (FibroTx, Estonia). TAP consists of a multiplex capture-antibody micro-array that is supported by a dermal adhesive bandage for fixture to skin. When TAP is applied to skin and left on for 20 minutes, the antibodies printed on the micro-array capture biomarkers from skin through immune recognition. Biomarkers (IL-1a, IL-1b, TNF-a, IL-8, IL-6, IL-17) captured from skin by TAP are qualitatively and quantitatively analyzed by spot-ELISA by a specific TAP analyzer.
Time frame: Day 0, day 7, day 14, day 21, day 28 and day 42
Pharmacodynamic endpoints 7 - Change in skin microbiota
The skin swab will be placed in a 2 ml lysis tube containing DNA/RNA shield to stabilize and preserve the DNA. The DNA extraction will be performed using adapted DNA extraction method based on the Zymo Research fecal DNA extraction methodology. The microbiome will be analyzed according to 16S rRNA gene sampling
Time frame: Day 0, day 7, day 14, day 21, day 28 and day 42
Pharmacodynamic endpoints 8 - Change over time in p. acnes cultures
Swabs of predefined lesional (papule of pustule) and non-lesional skin will be taken with a sterile cotton swab. Colony numbers (colony forming units - CFU) and minimal inhibitory concentrations (MIC) will be reported. In addition, swabs of other lesions (i.e. nodules or scars) may be taken if applicable. Moreover, in order to study P. acnes in the pilosebaceous unit a comedo extraction will be performed and the sebum will be cultured for P. acnes. Comedo extraction will be performed if applicable (i.e. if the patient has comedones).
Time frame: Day 0, day 7, day 14, day 21, day 28 and day 42
Pharmacodynamic endpoints 9 - Change over time in faecal microbiota
Faecal samples will be collected at home. Subjects will use a 'faeces catcher' in their toilet and afterwards use a cotton swab to transfer a scoop of faeces to a 2 ml lysis tube (REF ZY-R1103, Zymo Research) containing DNA/RNA shield to stabilize and preserve the DNA.
Time frame: before day 0 and after day 28
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Centre for Human Drug Research, Netherlands