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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05014906
Recruitment Status : Completed
First Posted : August 20, 2021
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
Dermatology Specialists Research

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
Rosacea 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.

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Study Type : Interventional  (Clinical Trial)
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 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Acne Rosacea

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 Name: Solodyn

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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Tolerability of treatment per group [ Time Frame: 12 Week ]
    Summary of adverse events suspected as related to study medication per treatment group



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05014906


Locations
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United States, Kentucky
Dermatology Specialists
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
Dermatology Specialists Research
Investigators
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Principal Investigator: James M Jackson, MD Dermatology Specialists
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Responsible Party: Dermatology Specialists Research
ClinicalTrials.gov Identifier: NCT05014906    
Other Study ID Numbers: ROS001
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021
Keywords provided by Dermatology Specialists Research:
rosacea
Additional relevant MeSH terms:
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Rosacea
Skin Diseases
Minocycline
Azelaic acid
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Dermatologic Agents