Efficacy of Oral Minocycline (Solodyn) and Oral Minocycline (Solodyn) Plus Azelaic Acid (Finacea) for Acne Rosacea

NCT05014906 | Completed Phase 4

• 1 other identifier: ROS001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Rosacea is one of the most commonly occurring dermatoses treated by dermatologist today. Rosacea is an inflammatory condition of the skin presenting as flushing and or blushing along with redness, swelling, telangiectasia, and acne lesions. Minocycline has shown beneficial in the treatment of inflammatory acne lesions in patients with rosacea. This study is to evaluate the efficacy and tolerability of minocycline (Solodyn) alone versus minocycline (Solodyn) in combination with azelaic acid 15%(Finacea) in the treatment of rosacea.

Conditions

Rosacea

Keywords

rosacea

Outcome Measures

Primary Outcomes (1)

• Efficacy analysis of the 12-week reduction in total lesion count

  The goal of analysis is to assess evidence of overall effect of 45mg minocycline and overall effect of 45 mg minocycline plus 15% azelaic acid in therapy of patients with acne rosacea.

  12 weeks

Secondary Outcomes (2)

• Efficacy analysis of the12 week reduction in IGA (Investigators Global Assessment) per treatment group

  12 Weeks

• Efficacy analysis of the 12-week reduction in CEA (Clinical Erythema Assessment) per treatment group

  12 Weeks

Other Outcomes (1)

• Tolerability of treatment per group

  12 Week

Study Arms (2)

minocycline, azelaic acid

ACTIVE COMPARATOR

minocycline vs minocycline in comination with 15% azelaic acid for treatment of rosacea

Drug: Minocycline 45 MG; Drug: Azelaic acid

azelaic acid

EXPERIMENTAL

45 mg oral minocycline vs 45 mg oral minocycline plus 15% azelaic acid in the treatment of facial rosacea

Drug: Minocycline 45 MG; Drug: Azelaic acid

Interventions

Minocycline 45 MG DRUG

45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid

Also known as: Solodyn

azelaic acid; minocycline, azelaic acid

Azelaic acid DRUG

45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid

Also known as: finacea

azelaic acid; minocycline, azelaic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18 or older with clinical diagnosis of rosacea
• must have 10-40 facial inflammatory lesions and less than 2 nodules
• women of child bearing potential must be non lactating
• must have negative urine pregnancy test
• must use effective form of birth control

You may not qualify if:

• The use of systemic antibiotics within 30 days of study start
• the use of topical medications within 14 - 30 days of study start depending on type of topical medication
• Patients with known sensitivity to tetracyclines
• Patients who have had gastric bypass surgery or are considered achlorhydric
• Patients taking drugs known as photosensitizers

Sponsors & Collaborators

• Dermatology Specialists Research: lead

Study Sites (1)

Dermatology Specialists

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

Minocycline; azelaic acid

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• James M Jackson, MD

  Dermatology Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: August 20, 2021
• Study Start: May 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

US (1)