E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10000496 |
E.1.2 | Term | Acne |
E.1.2 | System Organ Class | 10040785 - Skin and subcutaneous tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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;
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |