RosaceaPhase 2NCT01614743

A Double-Blinded, Randomized Placebo Controlled Pilot Study Comparing the Efficacy and Safety of IncobotulinumtoxinA Versus Saline Injections to the Cheek Region in Patients With Rosacea

A Phase 2 study testing IncobotulinumtoxinA and Bacteriostatic saline in people with Rosacea, run by DeNova Research at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a double-blinded, randomized placebo controlled pilot study comparing the efficacy and safety of incobotulinumtoxinA versus saline injections to the cheek region in patients with rosacea. The pilot study will enroll and treat a total of 10 subjects who present with rosacea of the cheek area. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Rosacea
What is being tested?: IncobotulinumtoxinA and Bacteriostatic saline
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 9 participants
Where: 1 siteUnited States
Study dates: Jun 2012to Nov 2013
Phase: Phase 2
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males and females between 18 and 65 years of age.
Subjects presenting with rosacea in the cheek area.
Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history:
postmenopausal for at least 12 months prior to study drug administration
without a uterus and/or both ovaries

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has had a bilateral tubal ligation for at least 6 months prior to study drug administration.
absence of an other physical condition according to the PI's discretion
Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).
Willingness and ability to provide written informed consent prior to performance of any study related procedure.

Who cannot join

Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
Subjects with a known allergy or sensitivity to any component of the study medications or anesthesia.
Topical or oral rosacea treatments within the past 2 weeks.
Subjects with a significant systemic illness or illness localized to the areas of treatment.
Botulinum toxin to the face within the past 6 months.
Significant concurrent illness such as diabetes, epilepsy, lupus, or congestive heart failure.

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Concurrent skin condition affecting area to be treated.
Prior surgery on the area to be treated within 3 months of initial treatment or during the study.
History or evidence of keloids or hypertrophic scarring.
Subjects currently using aminoglycoside antibiotics, curare-like agents or other agents that might interfere with neuromuscular function.
Subjects with a diagnosis of Myasthenia Gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral Sclerosis, or any other disease that might interfere with neuromuscular function or current facial palsy.
Current history of chronic drug or alcohol abuse.
Concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
Subjects who, in the Investigator's opinion, have a history of poor cooperation, non¬compliance with medical treatment or unreliability.
Enrollment in any active study involving the use of investigational devices or drugs.

Trial locations and contacts

1 site in 1 country.

United States1 site

DeNova Research
Chicago, Illinois, 60611

Other trials in United States

About this study

This is a double-blinded, randomized placebo controlled pilot study comparing the efficacy and safety of incobotulinumtoxinA versus saline injections to the cheek region in patients with rosacea.

The pilot study will enroll and treat a total of 10 subjects who present with rosacea of the cheek area. Upon study entry, subjects will be randomized to receive treatment with incobotulinumtoxinA or bacteriostatic saline to the cheek area. Study treatment will be prepared by an unblinded designee and both Physician Investigator (PI) and subject will remain blinded for the duration of the study. At the 16 week visit, control subjects will enter the rescue arm portion of the study and all study subjects will receive treatment with incobotulinumtoxinA to the cheek areas.

Conditions: Rosacea
Being tested: IncobotulinumtoxinA, Bacteriostatic saline
Keywords: Rosacea
Medical subject headings: Rosacea

What participants receive

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

IncobotulinumtoxinADrug
Experimental injection given at baseline and Week 16
Bacteriostatic salineDrug
Placebo at baseline, incobotulinumtoxinA at 16 weeks

Study groups in NCT01614743
Study group	Role	What they receive
IncobotulinumtoxinA	Experimental	Not described Receives: Drug: IncobotulinumtoxinA
Placebo	Placebo comparator	Not described Receives: Drug: Bacteriostatic saline

What is being measured

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

Percent Change From Baseline in the Rosacea Clinical Score Card
Live rosacea assessment for each side of the face using the Rosacea Clinical Scorecard for clinical assessment.The Rosacea Clinical Scorecard assesses the primary signs and symptoms of rosacea and is graded as absent (0), mild (1), moderate (2) or severe (3).
Measured: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks
Number of Participants Experiencing Adverse Events
Rate of adverse events
Measured: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks

Secondary outcomes (2)

Mean Heatherton & Polivy State Self-Esteem (HPSS) Scale Score at Baseline, 1, 4, 12, 16, 17, and 20 Weeks
Self-esteem change will be determined by patient self-evaluation using the Heatherton \& Polivy State Self-Esteem (HPSS) Scale.
Heatherton \& Polivy State Self-Esteem (HPSS) Scale includes three facets of self-esteem: Appearance, Performance, and Social The scale has a range of 20-100. A score closer to 100 signifies higher self-esteem, while a score closer to 20 signifies lower seld-esteem.
Measured: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks
Patient Satisfaction
4-point categorical assessment of patient satisfaction with treatment.
1. Highly Satisfied- Optimal cosmetic result
2. Very Satisfied- Obvious improvement in appearance form the initial condition, but not completely optimal for this subject
3. Satisfied- Marked improvement in appearance from initial condition
4. Unsatisfied- The appearance is essentially the same or worse as the original condition.
Measured: week 1, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks

Timeline

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

Jun 2012Nov 2013

First posted8 Jun 2012 (estimated)
Study startJun 2012
Primary completionNov 2013
Study completionNov 2013

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.
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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01614743
Sponsor's protocol ID: ROS-INC-12
Status last verified: Sep 2020
First submitted: 4 Jun 2012
Last updated: 8 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blinded, Randomized Placebo Controlled Pilot Study Comparing the Efficacy and Safety of IncobotulinumtoxinA Versus Saline Injections to the Cheek Region in Patients With Rosacea
ClinicalTrials.gov ID: NCT01614743
Acronym / sponsor ID: ROS-INC-12
Conditions: Rosacea
Keywords: Rosacea
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 9 participants (actual)
Lead sponsor: DeNova ResearchUniversity, hospital or other
Collaborators: Merz North America, Inc.
Study start: Jun 2012
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 8 Jun 2012 (estimated)
Results: Posted 14 Sep 2020

Clinical summary

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

This is a double-blinded, randomized placebo controlled pilot study comparing the efficacy and safety of incobotulinumtoxinA versus saline injections to the cheek region in patients with rosacea.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
IncobotulinumtoxinA	Experimental	Drug: IncobotulinumtoxinA
Placebo	Placebo comparator	Drug: Bacteriostatic saline

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Males and females between 18 and 65 years of age.
Subjects presenting with rosacea in the cheek area.
Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study.
Subjects of childbearing potential must have a negative urine pregnancy test result at Visit 1 and be willing able to use an acceptable method of birth control (e.g., barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following is documented on the medical history:
Willingness and ability to provide written photo consent and adherence to photography procedures (i.e., removal of jewelry and makeup).

Key exclusion criteria (15 listed)

Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control.
Subjects with a known allergy or sensitivity to any component of the study medications or anesthesia.
Topical or oral rosacea treatments within the past 2 weeks.
Subjects with a significant systemic illness or illness localized to the areas of treatment.
Botulinum toxin to the face within the past 6 months.

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
IncobotulinumtoxinAExperimental injection given at baseline and Week 16	Drug	IncobotulinumtoxinA
Bacteriostatic salinePlacebo at baseline, incobotulinumtoxinA at 16 weeks	Drug	Placebo

Primary outcome

Percent Change From Baseline in the Rosacea Clinical Score Card
Time frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks
Live rosacea assessment for each side of the face using the Rosacea Clinical Scorecard for clinical assessment.The Rosacea Clinical Scorecard assesses the primary signs and symptoms of rosacea and is graded as absent (0), mild (1), moderate (2) or severe (3).
Number of Participants Experiencing Adverse Events
Time frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks
Rate of adverse events

2 secondary outcomes

Mean Heatherton & Polivy State Self-Esteem (HPSS) Scale Score at Baseline, 1, 4, 12, 16, 17, and 20 Weeks
Time frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks
Patient Satisfaction
Time frame: week 1, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks

Results and safety

Results posted to the registry on 14 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IncobotulinumtoxinA at Baseline and Week 16	4	3
Placebo at Baseline, Then incobotulinumtoxinA at 16 Weeks	5	5

Primary outcome: Percent Change From Baseline in the Rosacea Clinical Score Card

Time frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks. Mean (Standard Deviation). Unit: percent change

Measure	Group 1 - IncobotulinumtoxinA n = 4	Group 2 - Bacteriostatic Saline n = 5
% Diff from baseline, Week 1	-0.63 (0.49)	-0.00063 (0.23)
% Diff from baseline, Week 4	-0.65 (0.60)	-0.34 (0.21)
% Diff from baseline, Week 12	-0.80 (0.61)	-0.13 (0.13)
% Diff from baseline, Week 16	-0.67 (0.48)	-0.51 (0.34)
% Diff from baseline, Week 17	-0.83 (0.62)	-0.83 (0.64)
% Diff from baseline, Week 20	-1.04 (8.85)	-0.7 (0.53)

Primary outcome: Number of Participants Experiencing Adverse Events

Time frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks. Number. Unit: participants

Measure	Group 1 - IncobotulinumtoxinA n = 4	Group 2 - Bacteriostatic Saline n = 5
Value	0	0

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 - IncobotulinumtoxinA	0 of 4 (0%)	0 of 4 (0%)	Not reported
Group 2 - Bacteriostatic Saline	0 of 5 (0%)	0 of 5 (0%)	Not reported

Limitations and caveats (from the sponsor): The limitation of this study was a very small sample size.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Rosacea

RecruitingPhase 2
A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)
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Recruiting
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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.

Steven H Dayan, MD principal investigator

DeNova Research

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IncobotulinumtoxinA and Bacteriostatic saline in people with Rosacea, run by DeNova Research 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 10 inclusion and 15 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: finished, as of the sponsor's last update on 8 Oct 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 14 Sep 2020). 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?

Percent Change From Baseline in the Rosacea Clinical Score Card (time frame: baseline, 1 week, 4 weeks, 12 weeks, 16 weeks, 17 weeks and 20 weeks). The study lists 2 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 NCT01614743.

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 8 Oct 2020.