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

Primary Purpose

Rosacea

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Minocycline 45 MG
Azelaic acid
Sponsored by
Dermatology Specialists Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Rosacea focused on measuring rosacea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dermatology Specialists

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

minocycline, azelaic acid

azelaic acid

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Efficacy analysis of the12 week reduction in IGA (Investigators Global Assessment) per treatment group
Summary of the 12-week reduction in IGA for the full sample, by treatment group
Efficacy analysis of the 12-week reduction in CEA (Clinical Erythema Assessment) per treatment group
Summary of the 12 week reduction in CEA for the full sample, by treatment group

Full Information

First Posted
November 22, 2013
Last Updated
August 13, 2021
Sponsor
Dermatology Specialists Research
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1. Study Identification

Unique Protocol Identification Number
NCT05014906
Brief Title
Efficacy of Oral Minocycline (Solodyn) and Oral Minocycline (Solodyn) Plus Azelaic Acid (Finacea) for Acne Rosacea
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 Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dermatology Specialists Research

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
Keywords
rosacea

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
minocycline, azelaic acid
Arm Type
Active Comparator
Arm Description
minocycline vs minocycline in comination with 15% azelaic acid for treatment of rosacea
Arm Title
azelaic acid
Arm Type
Experimental
Arm Description
45 mg oral minocycline vs 45 mg oral minocycline plus 15% azelaic acid in the treatment of facial rosacea
Intervention Type
Drug
Intervention Name(s)
Minocycline 45 MG
Other Intervention Name(s)
Solodyn
Intervention Description
45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid
Intervention Type
Drug
Intervention Name(s)
Azelaic acid
Other Intervention Name(s)
finacea
Intervention Description
45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid
Primary Outcome Measure Information:
Title
Efficacy analysis of the 12-week reduction in total lesion count
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Efficacy analysis of the12 week reduction in IGA (Investigators Global Assessment) per treatment group
Description
Summary of the 12-week reduction in IGA for the full sample, by treatment group
Time Frame
12 Weeks
Title
Efficacy analysis of the 12-week reduction in CEA (Clinical Erythema Assessment) per treatment group
Description
Summary of the 12 week reduction in CEA for the full sample, by treatment group
Time Frame
12 Weeks
Other Pre-specified Outcome Measures:
Title
Tolerability of treatment per group
Description
Summary of adverse events suspected as related to study medication per treatment group
Time Frame
12 Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James M Jackson, MD
Organizational Affiliation
Dermatology Specialists
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dermatology Specialists
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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