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

Sponsor
Dermatology Specialists Research (Other)
Overall Status
Completed
CT.gov ID
NCT05014906
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
16
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Minocycline 45 MG
  • Drug: Azelaic acid
 Phase 4

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Basic Science
Official Title:
Efficacy of 45mg Oral Minocycline (Solodyn) and 45mg Oral Minocycline (Solodyn) Plus 15% Azelaic Acid (Finacea) in the Treatment of Acne Rosacea
Study Start Date :
May 1, 2010
Actual Primary Completion Date :
Sep 1, 2011
Actual Study Completion Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: minocycline, azelaic acid

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

Drug: Minocycline 45 MG
45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid
Other Names:
  • Solodyn

    • Drug: Azelaic acid
    45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid
    Other Names:
  • finacea

    		•
    Experimental: azelaic acid

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

    Drug: Minocycline 45 MG
    45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid
    Other Names:
  • Solodyn

    • Drug: Azelaic acid
    45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid
    Other Names:
  • finacea

    		•

    Outcome Measures

    Primary Outcome Measures

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

    1. Efficacy analysis of the12 week reduction in IGA (Investigators Global Assessment) per treatment group [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 [12 Weeks]

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

    Other Outcome Measures

    1. Tolerability of treatment per group [12 Week]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dermatology Specialists Louisville Kentucky United States 40202

    Sponsors and Collaborators

    • Dermatology Specialists Research

    Investigators

    • Principal Investigator: James M Jackson, MD, Dermatology Specialists

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dermatology Specialists Research
    ClinicalTrials.gov Identifier:
    NCT05014906
    Other Study ID Numbers:
    • ROS001
    First Posted:
    Aug 20, 2021
    Last Update Posted:
    Aug 20, 2021
    Last Verified:
    Aug 1, 2021
    Keywords provided by Dermatology Specialists Research
    rosacea
    Additional relevant MeSH terms:
    Rosacea
    Minocycline
    Azelaic acid

    Study Results

    No Results Posted as of Aug 20, 2021