Atralin Gel for the Treatment of Rosacea

NCT01125930 | Terminated Phase 3 Results

• 1 other identifier: Derm 616
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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).

Conditions

Rosacea

Keywords

rosacea; tretinoin; atralin

Outcome Measures

Primary Outcomes (8)

• 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

  24 weeks

• 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

  24 weeks

• 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

  24 weeks

• 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

  24 weeks

• 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?".

  24 weeks

• 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.

  24 weeks

• 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.

  24 weeks

• 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.

  24 weeks

Secondary Outcomes (18)

• Quality of Life

  2, 6, 12, 18, 24 weeks

• Photodamage

  24 weeks

• Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea

  2, 6, 12, 18 and 24 weeks

• Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea

  2, 6, 12, 18 and 24 weeks

• Signs of Other Rosacea Subtypes: Papulopustular

  2, 6, 12, 18, 24 weeks

Study Arms (2)

Vehicle gel

PLACEBO COMPARATOR

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: vehicle gel

Atralin gel

ACTIVE COMPARATOR

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.

Drug: Atralin gel

Interventions

vehicle gel DRUG

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.

Vehicle gel

Atralin gel DRUG

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.

Atralin gel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lisa E. Maier: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

University of Michigan Department of Dermatology

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (3)

• 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.

  PMID: 15389184 BACKGROUND

• 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.

  PMID: 8129410 BACKGROUND

• 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.

  PMID: 10473962 BACKGROUND

MeSH Terms

Conditions

Rosacea

Interventions

Atralin Gel

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

Early termination of study due to slow recruitment and sponsor request resulted in smaller number of subjects analyzed.

Results Point of Contact

• Title: Dr. Lisa Maier
• Organization: University of Michigan

maierl@med.umich.edu

734-936-4192

Study Officials

• Lisa E Maier, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 13, 2010
• First Posted: May 19, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 16, 2014
• Results First Posted: July 16, 2014

Record last verified: 2014-07

Locations

US (1)