Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients

Center for Human Drug Research (CHDR)

Status and phase: Enrolling; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: 70% topical ethanol solution; Drug: Clindamycin 1% topical lotion formulation; Drug: Erythromycin 4% topical gel formulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03883269

CHDR1732

Details and patient eligibility

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 3 patient groups, including a placebo group

Erythromycin 4%

Experimental group

Description:

Erythromycin 4% topical gel formulation, BID, 4 weeks

Treatment:

Drug: Erythromycin 4% topical gel formulation

Clindamycin 1%

Experimental group

Description:

Clindamycin 1% topical lotion formulation, BID, 4 weeks

Treatment:

Drug: Clindamycin 1% topical lotion formulation

ethanol solution

Placebo Comparator group

Description:

70% topical ethanol solution, BID, 4 weeks

Treatment:

Drug: 70% topical ethanol solution