Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Atralin Gel for the Treatment of Rosacea

This study has been terminated.
(Due to slow recruitment and sponsor request study ended early)
Sponsor:
Collaborator:
Valeant Pharmaceuticals International, Inc.
Information provided by (Responsible Party):
Lisa E. Maier, University of Michigan
ClinicalTrials.gov Identifier:
NCT01125930
First received: May 13, 2010
Last updated: July 15, 2014
Last verified: July 2014

May 13, 2010
July 15, 2014
May 2010
January 2013   (final data collection date for primary outcome measure)
  • Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance.
  • Severity of erythematotelangiectatic rosacea signs [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Severity of erythematotelagiectatic rosacea signs will be measured by taking into account the following: redness, telangiectasia, facial edema, dry skin
  • Severity of erythematotelangiectatic rosacea symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Complete list of historical versions of study NCT01125930 on ClinicalTrials.gov Archive Site
  • Quality of Life [ Time Frame: 2, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2, 6, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
    Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea
  • Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea [ Time Frame: 2, 6, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
    Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea
  • Signs of Other Rosacea Subtypes: Papulopustular [ Time Frame: 2, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]
    Signs of other rosacea subtypes includes papulopustular, inflammatory papule count
  • Molecular Markers of Inflammation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: No ]
    Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
  • Severity of Erythematotelangiectatic Signs: Telangiectasia [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: No ]
    Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
  • Severity of Erythematotelangiectatic Signs: Facial Edema [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: No ]
    Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
  • Severity of Erythematotelangiectatic Signs: Dryness/Irritation [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: No ]
    Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
  • Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: No ]
    Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
  • Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: No ]
    Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
  • Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: No ]
    Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
  • Skin Irritation Assessed by Facial Stinging Upon Product Application [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: Yes ]
  • Skin Irritation Assessed by Facial Itching Upon Product Application [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: Yes ]
  • Skin Irritation Assessed by Facial Burning Upon Product Application [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: 2, 6, 12, 18, 24 weeks ] [ Designated as safety issue: No ]
  • Photodamage [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Signs of other rosacea subtypes [ Time Frame: 2, 6, 12, 18 and 24 weeks ] [ Designated as safety issue: No ]
    ocular, phymatous or papulopustular manifestations of rosacea
  • Molecular markers of inflammation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    These will be evaluated from skin biopsy from some subjects at baseline and final evaluation at 24 weeks.
  • Molecular evidence of photodamage [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    These will be evaluated from skin biopsy from some subjects at baseline and final evaluation at 24 weeks.
  • Severity of erythematotelangiectatic signs [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: No ]
  • Severity of erythematotelangiectatic rosacea symptoms [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: No ]
  • Skin irritation [ Time Frame: 2, 6, 12, 18 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Atralin Gel for the Treatment of Rosacea
Investigation of the Topical Retinoid, Atralin Gel 0.05% for the Treatment of Erythematotelangiectatic Rosacea

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Rosacea
  • Drug: vehicle gel
    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.
  • Drug: Atralin gel
    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.
  • Placebo Comparator: Vehicle gel
    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: Drug: vehicle gel
  • Active Comparator: Atralin gel
    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: Drug: Atralin gel

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
68
January 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Subjects 18 years of age and older of any race.
  2. Clinical diagnosis of mild to moderate erythematotelangiectatic facial rosacea based on physician evaluation.
  3. Willing and able to understand and sign informed consent.
  4. Able to complete study and comply with study procedures.

Exclusion Criteria:

  1. Severe self reported facial sensitivity
  2. History of allergy to fish
  3. Severe sun sensitivity
  4. Severe erythematotelangiectatic rosacea requiring systemic treatment
  5. Papulopustular, Ocular-only, Phymatous rosacea, Steroid rosacea, pyoderma faciale
  6. Unwilling to undergo facial biopsies
  7. Concomitant use of medications that are reported to exacerbate rosacea, such as topical and systemic steroids
  8. Use of topical rosacea treatments in the past 2 weeks.
  9. Use of systemic antibiotics in the past 4 weeks.
  10. Use of systemic retinoids within the past 6 months.
  11. Use of topical retinoids within the past 3 months
  12. Use of laser or light based rosacea treatments within the past 2 months.
  13. Cosmetic procedures (e.g., superficial chemical peels, exfoliation or microdermabrasion of the face) within the past two months
  14. Use of topical anti-aging medications including alpha hydroxy acids, salicylic acid, beta-hydroxy acid, vitamin A, vitamin E, ascorbic acid
  15. Other dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments.
  16. 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.
  17. 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).
  18. Subjects who are lactating.
  19. Use of any investigational therapy within the past 4 weeks.
  20. Known hypersensitivity or previous allergic reaction to retinoids
  21. Carcinoid, Pheochromocytoma or other systemic flushing causes
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01125930
Derm 616
No
Lisa E. Maier, University of Michigan
Lisa E. Maier
Valeant Pharmaceuticals International, Inc.
Principal Investigator: Lisa E Maier, M.D. University of Michigan
University of Michigan
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP