Acne vulgaris MedDRA version: 20.0 Level: PT Classification code 10000496 Term: Acne System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Erythromycin 4% topical gel formulation
Product Name: Erythromycin 4% topical gel formulation
Pharmaceutical Form: Gel
INN or Proposed INN: ERYTHROMYCIN
Other descriptive name: erythromyci
Sponsors
Centre for Human Drug Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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; 2. Mild to moderate inflammatory acne vulgaris on the face, =5 inflammatory lesions (papules and/or pustules), present at screening and baseline visit 3. A maximum of 5 nodules present at screening and baseline visit 4. Inflammatory acne present for at least 6 months 5. Fitzpatrick skin type I-II (Caucasian) 6. Able and willing to give written informed consent and to comply with the study restrictions. 7. Willing to comply with 2x2mm facial skin punch biopsies Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Severe acne where systemic treatment is needed 2. Use of any topical (anti-acne) medication (prescription or OTC) within 2 weeks prior to baseline 3. Use of any oral/systemic treatment for acne, including oral antibiotics, excluding OAC, within 4 weeks prior to baseline 4. Use of systemic isotretinoin within 6 months prior to baseline 5. History of pathological scar formation (keloid, hypertrophic scar) 6. Known hypersensitivity to erythromycin or clindamycin, drugs of the same class, or any of their excipients. 7. Known contact dermatitis reaction to any product 8. Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment. 9. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year. 10. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening 11. Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objectives • To evaluate the effects of topically applied erythromycin and clindamycin in patients with facial AV • To explore skin and faecal microbiota in patients with AV; • To evaluate the effects of topically applied erythromycin and clindamycin on skin and faecal microbiota; ;Secondary Objective: Not Applicable;Primary end point(s): Efficacy endpoints • Lesion count • Investigator Global Assessment acne (IGA) Pharmacodynamic endpoints • Standardized facial photography by Canfield Visia and via selfie app • Sebum measurements by Sebumeter® • Perfusion by Laser Speckle Contrast Imaging (LSCI) • Morphology by Optical Coherence Tomography (OCT) • Local skin biopsy biomarkers (IL-1b, IL-1a, TNF-a IL-6, IL-12, IL-8, IL-10, IL-17, IFN-g) • Change in skin microbiota (16S NGS sequencing (lesional vs non-lesional)) • Change over time in p.acnes cultures • Change over time in faecal microbiota • Local skin surface biomarkers by TAP (IL-1a, IL-1b, TNF-a, IL-8, IL-10, IL-17) Patient Reported Outcome (PRO) • Subjective patient global assessment (sPGA) ;Timepoint(s) of evaluation of this end point: Day 0 until Day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not Applicable;Timepoint(s) of evaluation of this end point: Not Applicable | — |
Countries
Netherlands
Contacts
Public ContactPrincipal Investigator
Centre for Human Drug Research
Outcome results
None listed