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

NCT ID: NCT03883269

Last Updated: 2019-03-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-20
• Study Completion Date: 2019-12-31

Brief Summary

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Erythromycin 4%

Erythromycin 4% topical gel formulation, BID, 4 weeks

Group Type: EXPERIMENTAL

Erythromycin 4% topical gel formulation

Intervention Type: DRUG

Erythromycin 4% topical gel formulation, BID, 4 weeks

Clindamycin 1%

Clindamycin 1% topical lotion formulation, BID, 4 weeks

Group Type: EXPERIMENTAL

Clindamycin 1% topical lotion formulation

Intervention Type: DRUG

Clindamycin 1% topical lotion formulation, BID, 4 weeks

ethanol solution

70% topical ethanol solution, BID, 4 weeks

Group Type: PLACEBO_COMPARATOR

70% topical ethanol solution

Intervention Type: DRUG

70% topical ethanol solution, BID, 4 weeks

Interventions

Erythromycin 4% topical gel formulation

Erythromycin 4% topical gel formulation, BID, 4 weeks

Intervention Type: DRUG

Clindamycin 1% topical lotion formulation

Clindamycin 1% topical lotion formulation, BID, 4 weeks

Intervention Type: DRUG

70% topical ethanol solution

70% topical ethanol solution, BID, 4 weeks

Intervention Type: DRUG

Eligibility 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Maruho Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Centre for Human Drug Research, Netherlands

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Rissmann, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHDR

Locations

Centre for Human Drug Research

Leiden, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Robert Rissmann, PharmD, PhD

Role: CONTACT

clintrials@chdr.nl

+31 71 5246 400

Diana Noort

Role: CONTACT

clintrials@chdr.nl

+31 71 5246 400

Facility Contacts

Robert Rissmann, PharmD, PhD

Role: primary

clintrials@chdr.nl

+31 71 5246 400

Diana Noort

Role: backup

clintrials@chdr.nl

+31 71 5246 400

Other Identifiers

CHDR1732

Identifier Type: -

Identifier Source: org_study_id