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New treatment option for Acne Vulgaris
Official title Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients
ClinicalTrials.gov ID: NCT03883269
What this study is testing
What is Erythromycin 4% topical gel formulation?
Erythromycin 4% topical gel formulation is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for acne vulgaris.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45. Healthy volunteers may be eligible.
You may be able to join if
- Healthy male and female people, 18 to 45 years of age. The health status is verified by absence of evidence of any clinical significant active or...
- Mild to moderate inflammatory acne vulgaris on the face, ≥5 inflammatory lesions (papules and/or pustules), present at screening and baseline visit
- A maximum of 5 nodules present at screening and baseline visit
- Inflammatory acne present for at least 6 months
- Fitzpatrick skin type I-II (Caucasian)
You likely can't join if
- Severe acne where systemic treatment is needed
- Use of any topical (anti-acne) medication (prescription or OTC) within 2 weeks prior to baseline
- Use of any oral/systemic treatment for acne, including oral antibiotics, excluding OAC, within 4 weeks prior to baseline
- Use of systemic isotretinoin within 6 months prior to baseline
- History of pathological scar formation (keloid, hypertrophic scar)
- Known hypersensitivity to erythromycin or clindamycin, drugs of the same class, or any of their excipients.
See the full eligibility criteria
- Healthy male and female people, 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...
- Mild to moderate inflammatory acne vulgaris on the face, ≥5 inflammatory lesions (papules and/or pustules), present at screening and baseline visit
- A maximum of 5 nodules present at screening and baseline visit
- Inflammatory acne present for at least 6 months
- Fitzpatrick skin type I-II (Caucasian)
- Able and willing to give written informed consent and to comply with the study restrictions.
- Willing to comply with 2x2mm facial skin punch biopsies
- Severe acne where systemic treatment is needed
- Use of any topical (anti-acne) medication (prescription or OTC) within 2 weeks prior to baseline
- Use of any oral/systemic treatment for acne, including oral antibiotics, excluding OAC, within 4 weeks prior to baseline
- Use of systemic isotretinoin within 6 months prior to baseline
- History of pathological scar formation (keloid, hypertrophic scar)
- Known hypersensitivity to erythromycin or clindamycin, drugs of the same class, or any of their excipients.
- Known contact dermatitis reaction to any product
- Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment.
- Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.
- Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening
- Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Leiden, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leiden, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.