RosaceaPhase 3NCT01125930

Atralin Gel for the Treatment of Rosacea

A Phase 3 study testing Atralin gel in people with Rosacea, run by Lisa E. Maier at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Rosacea
What is being tested?: Atralin gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: 1 siteUnited States
Study dates: May 2010to Jan 2013
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 21Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan Department of Dermatology
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: 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).

Conditions: Rosacea
Being tested: vehicle gel, Atralin gel
Keywords: rosacea, tretinoin, atralin
Medical subject headings: Rosacea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

vehicle gelDrug
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.
Atralin gelDrug
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.

Study groups in NCT01125930
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Atralin gel

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: 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
Measured: 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
Measured: 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?".
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 weeks

Secondary outcomes (18)

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.
Measured: 2, 6, 12, 18, 24 weeks
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.
Measured: 24 weeks
Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea
Signs of other rosacea subtypes using rosacea clinical scores: ocular manifestations of rosacea
Measured: 2, 6, 12, 18 and 24 weeks
Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea
Signs of other rosacea subtypes using rosacea clinical scores: phymatous changes of rosacea
Measured: 2, 6, 12, 18 and 24 weeks
Signs of Other Rosacea Subtypes: Papulopustular
Signs of other rosacea subtypes includes papulopustular, inflammatory papule count
Measured: 2, 6, 12, 18, 24 weeks
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).
Measured: 24 weeks
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).
Measured: 24 weeks
Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)
Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Measured: 2, 6, 12, 18 weeks
Severity of Erythematotelangiectatic Signs: Telangiectasia
Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Measured: 2, 6, 12, 18 weeks
Severity of Erythematotelangiectatic Signs: Facial Edema
Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Measured: 2, 6, 12, 18 weeks
Severity of Erythematotelangiectatic Signs: Dryness/Irritation
Severity of erythematotelangiectatic signs include redness (non-transient erythema), telangiectasia, facial edema, and dry skin.
Measured: 2, 6, 12, 18 weeks
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
Measured: 2, 6, 12, 18 weeks
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning
Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Measured: 2, 6, 12, 18 weeks
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging
Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Measured: 2, 6, 12, 18 weeks
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment
Evaluation of erythematotelangiectatic rosacea symptoms includes subject reporting of flushing, burning, stinging, topical product intolerance
Measured: 2, 6, 12, 18 weeks
Skin Irritation Assessed by Facial Stinging Upon Product Application
Measured: 2, 6, 12, 18 weeks
Skin Irritation Assessed by Facial Itching Upon Product Application
Measured: 2, 6, 12, 18 weeks
Skin Irritation Assessed by Facial Burning Upon Product Application
Measured: 2, 6, 12, 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Jan 2013

First posted19 May 2010 (estimated)
Study startMay 2010
Primary completionJan 2013
Study completionJan 2013

Why it stopped: Due to slow recruitment and sponsor request study ended early

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for RosaceaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01125930
Sponsor's protocol ID: Derm 616
Status last verified: Jul 2014
First submitted: 13 May 2010
Last updated: 16 Jul 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 15389184
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.
PubMed 8129410
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.
PubMed 10473962

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rosacea trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Topical Retinoid, Atralin Gel 0.05% for the Treatment of Erythematotelangiectatic Rosacea
ClinicalTrials.gov ID: NCT01125930
Acronym / sponsor ID: Derm 616
Conditions: Rosacea
Keywords: rosacea, tretinoin, atralin
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Due to slow recruitment and sponsor request study ended early
Enrolment: 68 participants (actual)
Lead sponsor: Lisa E. MaierUniversity, hospital or other
Collaborators: Bausch Health Americas, Inc.
Study start: May 2010
Primary completion: Jan 2013 (actual)
Study completion: Jan 2013 (actual)
First posted: 19 May 2010 (estimated)
Results: Posted 16 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Vehicle gel	Placebo comparator	Drug: vehicle gelTopical 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.
Atralin gel	Active comparator	Drug: Atralin gelTopical 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (21 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
vehicle gelTopical 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 gelTopical 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

Primary outcome

Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)
Time frame: 24 weeks
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
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
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
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
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
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
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
Severity of erythematotelangiectatic rosacea symptoms was assessed by asking subjects to give an overall self-assessment of product tolerance.

18 secondary outcomes

Quality of Life
Time frame: 2, 6, 12, 18, 24 weeks
Photodamage
Time frame: 24 weeks
Signs of Other Rosacea Subtypes: Ocular Manifestations of Rosacea
Time frame: 2, 6, 12, 18 and 24 weeks
Signs of Other Rosacea Subtypes: Phymatous Changes of Rosacea
Time frame: 2, 6, 12, 18 and 24 weeks
Signs of Other Rosacea Subtypes: Papulopustular
Time frame: 2, 6, 12, 18, 24 weeks
Molecular Markers of Inflammation
Time frame: 24 weeks
Molecular Evidence of Photodamage
Time frame: 24 weeks
Severity of Erythematotelangiectatic Signs: Non-Transient Erythema (Redness)
Time frame: 2, 6, 12, 18 weeks
Severity of Erythematotelangiectatic Signs: Telangiectasia
Time frame: 2, 6, 12, 18 weeks
Severity of Erythematotelangiectatic Signs: Facial Edema
Time frame: 2, 6, 12, 18 weeks
Severity of Erythematotelangiectatic Signs: Dryness/Irritation
Time frame: 2, 6, 12, 18 weeks
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Presence of Flushing
Time frame: 2, 6, 12, 18 weeks
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Burning
Time frame: 2, 6, 12, 18 weeks
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Facial Stinging
Time frame: 2, 6, 12, 18 weeks
Severity of Erythematotelangiectatic Rosacea Symptoms: Self-Reported Product Assessment
Time frame: 2, 6, 12, 18 weeks
Skin Irritation Assessed by Facial Stinging Upon Product Application
Time frame: 2, 6, 12, 18 weeks
Skin Irritation Assessed by Facial Itching Upon Product Application
Time frame: 2, 6, 12, 18 weeks
Skin Irritation Assessed by Facial Burning Upon Product Application
Time frame: 2, 6, 12, 18 weeks

Results and safety

Results posted to the registry on 16 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vehicle Gel	22	21
Atralin Gel	46	36

Primary outcome: Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema)

Time frame: 24 weeks. Number. Unit: participants

Measure	Vehicle Gel n = 21	Atralin Gel n = 36
None	0	0
Mild Erythema	12	22
Moderate Erythema	9	13
Marked Erythema	0	1
Deep Erythema	0	0

Vehicle Gel vs Atralin Gel: p = 0.93, Wilcoxon (Mann-Whitney)

Population analysed: Last Observation Carried Forward (LOCF), Complete-Case Intent-to-Treat (ITT) Population

Primary outcome: Severity of Erythematotelangiectatic Rosacea Signs: Telangiectasia

Time frame: 24 weeks. Number. Unit: participants

Measure	Vehicle Gel n = 21	Atralin Gel n = 36
None	1	0
Mild	10	22
Moderate	10	13
Severe	0	1

Vehicle Gel vs Atralin Gel: p = 0.79, Wilcoxon (Mann-Whitney)

Population analysed: LOCF, Complete-Case ITT population

Primary outcome: Severity of Erythematotelangiectatic Rosacea Signs: Facial Edema

Time frame: 24 weeks. Number. Unit: participants

Measure	Vehicle Gel n = 21	Atralin Gel n = 36
None	21	31
Mild	0	5
Moderate	0	0
Severe	0	0

Vehicle Gel vs Atralin Gel: p = 0.15, Wilcoxon (Mann-Whitney)

Population analysed: LOCF, Complete-Case ITT Population

Primary outcome: Severity of Erythematotelangiectatic Rosacea Signs: Dry Skin

Time frame: 24 weeks. Number. Unit: participants

Measure	Vehicle Gel n = 21	Atralin Gel n = 36
None	13	16
Slight Flaking	7	12
Moderate Flaking/Scaling	1	8
Marked Scaling/Fissuring	0	0
Severe Scaling/Fissuring	0	0

Vehicle Gel vs Atralin Gel: p = 0.13, Wilcoxon (Mann-Whitney)

Population analysed: LOCF, Complete-Case ITT Population

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: Safety assessment was conducted for all subjects at each visit after enrollment in the study. The study duration could range from 24 to 46 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vehicle Gel	0 of 22 (0%)	13 of 22 (59.1%)	Not reported
Atralin Gel	1 of 46 (2.2%)	25 of 46 (54.3%)	Not reported

Limitations and caveats (from the sponsor): Early termination of study due to slow recruitment and sponsor request resulted in smaller number of subjects analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15389184Pelle 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.
Background: PubMed 8129410Ertl 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.
Background: PubMed 10473962Vienne 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lisa E Maier, M.D. principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Atralin gel in people with Rosacea, run by Lisa E. Maier at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severity of Erythematotelangiectatic Rosacea Signs: Redness (Non Transient Erythema) (time frame: 24 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01125930, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2014.