Back to resultsAtralin Gel for the Treatment of Rosacea
Primary Purpose
Rosacea
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
vehicle gel
Atralin gel
Sponsored by
About this trial
This is an interventional treatment trial for Rosacea focused on measuring rosacea, tretinoin, atralin
Eligibility Criteria
Inclusion Criteria:
- Subjects 18 years of age and older of any race.
- Clinical diagnosis of mild to moderate erythematotelangiectatic facial rosacea based on physician evaluation.
- Willing and able to understand and sign informed consent.
- Able to complete study and comply with study procedures.
Exclusion Criteria:
- Severe self reported facial sensitivity
- History of allergy to fish
- Severe sun sensitivity
- Severe erythematotelangiectatic rosacea requiring systemic treatment
- Papulopustular, Ocular-only, Phymatous rosacea, Steroid rosacea, pyoderma faciale
- Unwilling to undergo facial biopsies
- Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids
- Use of topical rosacea treatments in the past 2 weeks.
- Use of systemic antibiotics in the past 4 weeks.
- Use of systemic retinoids within the past 6 months.
- Use of topical retinoids within the past 3 months
- Use of laser or light based rosacea treatments within the past 2 months.
- Cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face) within the past two months
- Use of topical anti-aging medications including alpha hydroxy acids, salicylic acid, beta-hydroxy acid, vitamin A, vitamin E, ascorbic acid
- Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments.
- Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
- If female, Subjects who are either of non-child bearing potential (defined as postmenopausal -absence of menstrual bleeding for 1 year - or as having undergone bilateral tubal ligation, hysterectomy or bilateral ovariectomy) or, if of childbearing potential, Subjects who have had a negative urine pregnancy test at the beginning of the study, and have agreed to practice appropriate birth-control to prevent pregnancy during the study.(The type and dose of birth control must have been stable for at least 2 months prior to study entry and not be expected to change during the study).
- Subjects who are lactating.
- Use of any investigational therapy within the past 4 weeks.
- Known hypersensitivity or previous allergic reaction to retinoids
- Carcinoid, Pheochromocytoma or other systemic flushing causes
Sites / Locations
- University of Michigan Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Vehicle gel
Atralin gel
Arm Description
Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Outcomes
Primary Outcome Measures
Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)
Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia
Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema
Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin
Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing
Flushing is defined as a temporary redness of the face, neck and chest. Subjects were asked to choose the best answer that applied to them in response to the questions "Do you have flushing?".
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning
Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the facial burning feature of their rosacea.
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging
Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the Facial Stinging feature of their rosacea.
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product
Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance.
Secondary Outcome Measures
Quality of Life
The Dermatology Life Quality Index (DLQI) questionnaire was given at each visit. It involves 10 questions that relate to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The total DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Photodamage
Photodamage was measured at baseline and Week 24 visits using the nine point Hamilton-Griffiths Photoaging Score categories. The categories were developed using photographs of subject representing grades of photodamge from none (0) to severe (8). A direct comparison is made between the subject and the photographic standards. If an exact match cannot be made, the interstandard scores (1, 3, 5, 7) are used.
Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea
Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea
Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea
Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea
Signs of Other Rosacea Subtypes: Papulopustular
Signs of other rosacea subtypes includes papulopustular, inflammatory papule count
Molecular Markers of Inflammation
These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of inflammation include Tachykinin 1 (TAC1), CXC Motif Receptor 4 (CXCR4), CXC Motif Ligand 12 (CXCL12), and Tumor Necrosis Factor Alpha (TNFa).
Molecular Evidence of Photodamage
These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of photodamage include Collagen 1 (COL-1), Collagen 3 (COL-3), Matrix Metalloproteinase 1 (MMP1), Matrix Metalloproteinase 3 (MMP3), and Matrix Metalloproteinase 9 (MMP9).
Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)
Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Severity of Erythematotelangiectatic Signs: Telangiectasia
Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Severity of Erythematotelangiectatic Signs: Facial Edema
Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Severity of Erythematotelangiectatic Signs: Dryness/Irritation
Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing
Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning
Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging
Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment
Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Skin Irritation Assessed by Facial Stinging Upon Product Application
Skin Irritation Assessed by Facial Itching Upon Product Application
Skin Irritation Assessed by Facial Burning Upon Product Application
Full Information
NCT ID
NCT01125930
First Posted
May 13, 2010
Last Updated
July 15, 2014
Sponsor
Lisa E. Maier
Collaborators
Bausch Health Americas, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01125930
Brief Title
Atralin Gel for the Treatment of Rosacea
Official Title
Investigation of the Topical Retinoid, Atralin Gel 0.05% for the Treatment of Erythematotelangiectatic Rosacea
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
Due to slow recruitment and sponsor request study ended early
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lisa E. Maier
Collaborators
Bausch Health Americas, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Erythematotelangiectatic rosacea is a type of rosacea that causes a red face often with frequent flushing, topical sensitivity and prominent blood vessels. We think that long term damage to skin from the sun (photodamage) may play a role in causing this type of rosacea. Tretinoin is a topical medication that is known to improve photodamage. We want to find out if Atralin (tretinoin 0.05%) Gel used for up to 46 weeks will improve erythematotelangiectatic rosacea (ETR).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rosacea
Keywords
rosacea, tretinoin, atralin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vehicle gel
Arm Type
Placebo Comparator
Arm Description
Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Arm Title
Atralin gel
Arm Type
Active Comparator
Arm Description
Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Intervention Type
Drug
Intervention Name(s)
vehicle gel
Intervention Description
Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
Intervention Type
Drug
Intervention Name(s)
Atralin gel
Intervention Description
Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
Primary Outcome Measure Information:
Title
Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)
Description
Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Time Frame
24 weeks
Title
Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia
Description
Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Time Frame
24 weeks
Title
Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema
Description
Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Time Frame
24 weeks
Title
Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin
Description
Severity of erythematotelangiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
Time Frame
24 weeks
Title
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing
Description
Flushing is defined as a temporary redness of the face, neck and chest. Subjects were asked to choose the best answer that applied to them in response to the questions "Do you have flushing?".
Time Frame
24 weeks
Title
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning
Description
Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the facial burning feature of their rosacea.
Time Frame
24 weeks
Title
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging
Description
Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to rate the Facial Stinging feature of their rosacea.
Time Frame
24 weeks
Title
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Assessment of Product
Description
Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Quality of Life
Description
The Dermatology Life Quality Index (DLQI) questionnaire was given at each visit. It involves 10 questions that relate to symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. The total DLQI score is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time Frame
2, 6, 12, 18, 24 weeks
Title
Photodamage
Description
Photodamage was measured at baseline and Week 24 visits using the nine point Hamilton-Griffiths Photoaging Score categories. The categories were developed using photographs of subject representing grades of photodamge from none (0) to severe (8). A direct comparison is made between the subject and the photographic standards. If an exact match cannot be made, the interstandard scores (1, 3, 5, 7) are used.
Time Frame
24 weeks
Title
Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea
Description
Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea
Time Frame
2, 6, 12, 18 and 24 weeks
Title
Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea
Description
Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea
Time Frame
2, 6, 12, 18 and 24 weeks
Title
Signs of Other Rosacea Subtypes: Papulopustular
Description
Signs of other rosacea subtypes includes papulopustular, inflammatory papule count
Time Frame
2, 6, 12, 18, 24 weeks
Title
Molecular Markers of Inflammation
Description
These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of inflammation include Tachykinin 1 (TAC1), CXC Motif Receptor 4 (CXCR4), CXC Motif Ligand 12 (CXCL12), and Tumor Necrosis Factor Alpha (TNFa).
Time Frame
24 weeks
Title
Molecular Evidence of Photodamage
Description
These will be evaluated from skin biopsies from some subjects at baseline and final evaluation at 24 weeks. Gene expression data were normalized and presented as fold change from baseline to week 24 visit. Markers of photodamage include Collagen 1 (COL-1), Collagen 3 (COL-3), Matrix Metalloproteinase 1 (MMP1), Matrix Metalloproteinase 3 (MMP3), and Matrix Metalloproteinase 9 (MMP9).
Time Frame
24 weeks
Title
Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)
Description
Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Time Frame
2, 6, 12, 18 weeks
Title
Severity of Erythematotelangiectatic Signs: Telangiectasia
Description
Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Time Frame
2, 6, 12, 18 weeks
Title
Severity of Erythematotelangiectatic Signs: Facial Edema
Description
Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Time Frame
2, 6, 12, 18 weeks
Title
Severity of Erythematotelangiectatic Signs: Dryness/Irritation
Description
Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Time Frame
2, 6, 12, 18 weeks
Title
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing
Description
Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Time Frame
2, 6, 12, 18 weeks
Title
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning
Description
Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Time Frame
2, 6, 12, 18 weeks
Title
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging
Description
Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Time Frame
2, 6, 12, 18 weeks
Title
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment
Description
Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Time Frame
2, 6, 12, 18 weeks
Title
Skin Irritation Assessed by Facial Stinging Upon Product Application
Time Frame
2, 6, 12, 18 weeks
Title
Skin Irritation Assessed by Facial Itching Upon Product Application
Time Frame
2, 6, 12, 18 weeks
Title
Skin Irritation Assessed by Facial Burning Upon Product Application
Time Frame
2, 6, 12, 18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects 18 years of age and older of any race.
Clinical diagnosis of mild to moderate erythematotelangiectatic facial rosacea based on physician evaluation.
Willing and able to understand and sign informed consent.
Able to complete study and comply with study procedures.
Exclusion Criteria:
Severe self reported facial sensitivity
History of allergy to fish
Severe sun sensitivity
Severe erythematotelangiectatic rosacea requiring systemic treatment
Papulopustular, Ocular-only, Phymatous rosacea, Steroid rosacea, pyoderma faciale
Unwilling to undergo facial biopsies
Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids
Use of topical rosacea treatments in the past 2 weeks.
Use of systemic antibiotics in the past 4 weeks.
Use of systemic retinoids within the past 6 months.
Use of topical retinoids within the past 3 months
Use of laser or light based rosacea treatments within the past 2 months.
Cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face) within the past two months
Use of topical anti-aging medications including alpha hydroxy acids, salicylic acid, beta-hydroxy acid, vitamin A, vitamin E, ascorbic acid
Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments.
Clinically significant abnormal findings or conditions (other than rosacea), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
If female, Subjects who are either of non-child bearing potential (defined as postmenopausal -absence of menstrual bleeding for 1 year - or as having undergone bilateral tubal ligation, hysterectomy or bilateral ovariectomy) or, if of childbearing potential, Subjects who have had a negative urine pregnancy test at the beginning of the study, and have agreed to practice appropriate birth-control to prevent pregnancy during the study.(The type and dose of birth control must have been stable for at least 2 months prior to study entry and not be expected to change during the study).
Subjects who are lactating.
Use of any investigational therapy within the past 4 weeks.
Known hypersensitivity or previous allergic reaction to retinoids
Carcinoid, Pheochromocytoma or other systemic flushing causes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa E Maier, M.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Department of Dermatology
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
15389184
Citation
Pelle MT, Crawford GH, James WD. Rosacea: II. Therapy. J Am Acad Dermatol. 2004 Oct;51(4):499-512; quiz 513-4. doi: 10.1016/j.jaad.2004.03.033.
Results Reference
background
PubMed Identifier
8129410
Citation
Ertl GA, Levine N, Kligman AM. A comparison of the efficacy of topical tretinoin and low-dose oral isotretinoin in rosacea. Arch Dermatol. 1994 Mar;130(3):319-24.
Results Reference
background
PubMed Identifier
10473962
Citation
Vienne MP, Ochando N, Borrel MT, Gall Y, Lauze C, Dupuy P. Retinaldehyde alleviates rosacea. Dermatology. 1999;199 Suppl 1:53-6. doi: 10.1159/000051380.
Results Reference
background
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Atralin Gel for the Treatment of Rosacea
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