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Completed

NCT Number: NCT05014906

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

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.

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Key information

Conditions

Rosacea Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Dermatology Specialists

Louisville, Kentucky, 40202, United States

About this study

This is a multicenter, randomized, outpatient, Investigator-blind study of minocycline 45 mg and minocycline 45 mg plus 15% azelaic acid for the treatment of rosacea.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Minocycline 45 MG

Drug

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

Other names: Solodyn

Azelaic acid

Drug

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

Other names: finacea

Primary outcomes

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

    Time frame: 12 weeks

    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.

Secondary outcomes

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

    Time frame: 12 Weeks

    Summary of the 12-week reduction in IGA for the full sample, by treatment group

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

    Time frame: 12 Weeks

    Summary of the 12 week reduction in CEA for the full sample, by treatment group

Other outcomes

  1. Tolerability of treatment per group

    Time frame: 12 Week

    Summary of adverse events suspected as related to study medication per treatment group

Sponsors and collaborators

Lead sponsor

Dermatology Specialists Research

Other

Registry information

Official study title

Efficacy of 45mg Oral Minocycline (Solodyn) and 45mg Oral Minocycline (Solodyn) Plus 15% Azelaic Acid (Finacea) in the Treatment of Acne Rosacea

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 20, 2021
Registry last updated
Aug 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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