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TerminatedNCT03508869Updated Apr 18, 2023

Mirvaso® Gel and Dysport® for Erythema and Flushing of Rosacea

An interventional study of Mirvaso® (brimonidine) topical gel, 0.33% and Dysport® in Erythema and Flushing Associated With Rosacea, sponsored by Skin Laser & Surgery Specialists. Terminated. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by Skin Laser & Surgery Specialists · Not applicable, Interventional, and Treatment

Why this study was terminated
sponsor asked site to suspend study.
Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

To evaluate the safety and efficacy of Mirvaso® Gel and Dysport® for erythema and flushing of Rosacea.

Read the detailed description

To assess the improvement of facial erythema and flushing while using Mirvaso® and Dysport® treatments based on the clinician's and patient's assessments using a verified 5-point grading scale

02

Conditions studied

  • Erythema and Flushing Associated With Rosacea
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Male or female
  2. 18 years of age or older
  3. Clinical diagnosis of rosacea
  4. Moderate to severe persistent facial erythema associated with rosacea at baseline, as determined by: a grade of greater than or equal to 3 on the 5 point grading scale1 (Figure 1)
  5. No known medical conditions that may interfere with study participation
  6. Willingness to not use any products on their face for the duration of the study
  7. Read, understand, and sign informed consent forms
  8. Willingness to sign photography release form
  9. Willing and able to comply with all follow-up requirements
  10. Willingness to undergo treatment using Mirvaso® Gel and Dysport®

Exclusion criteria

Exclusion Criteria:

  1. Any significant skin disease at treatment area
  2. Any medical condition which could interfere with the treatment
  3. Inability or unwillingness to follow the treatment schedule
  4. Inability or unwillingness to sign the informed consent
  5. Pregnant or lactating
  6. Allergy to cow's milk protein
  7. Previous or current use of Mirvaso® Gel
  8. Known hypersensitivity to Dysport® , Mirvaso® Gel or any of their ingredients
  9. Previous Dysport® treatment 6 months prior to the screening visit
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Active comparator
    Mirvaso® (brimonidine) topical gel, 0.33%

    Mirvaso® (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent facial erythema of rosacea in adults 18 years of age or older.

    Drug: Mirvaso® (brimonidine) topical gel, 0.33%

  • Active comparator
    Dysport®

    Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.

    Drug: Dysport®

  • Active comparator
    Dysport® in conjunction with Mirvaso

    Dysport® in conjunction with Mirvaso

    Drug: Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%

Interventions

  • DrugMirvaso® (brimonidine) topical gel, 0.33%

    Mirvaso® (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent facial erythema of rosacea in adults 18 years of age or older.

  • DrugDysport®

    Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.

    Also known as: Dysport® (abobotulinumtoxinA)

  • DrugDysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%

    Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%

05

What researchers measure

Primary outcomes

  1. Efficacy Assessments for Erythema

    % of subjects who achieve a grade of 0 or 1 on the 5-point grading scale for Erythema 6 months post Dysport treatment Subject achieving a grade of 0 or 1 or ≥ 2 grade of improvement from baseline at 6 months for Erythema on the 5-point grading scale.

    Time frame: 6 months

  2. Efficacy Assessments for Flushing

    % of subjects who achieve a grade of 0 or 1 on the 5-point grading scale for Flushing 6 months post Dysport treatment Subject achieving a grade of 0 or 1 or ≥ 2 grade of improvement from baseline at 6 months for Flushing on the 5-point grading scale.

    Time frame: 6 months

Secondary outcomes

  1. Safety Assessments

    Safety evaluations will be performed at all visits. Adverse events, local tolerability (dryness, pruritus burning/stinging) and a facial exam will be performed for all visits.

    Time frame: 6 months

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03508869
Lead sponsor
Skin Laser & Surgery Specialists
Collaborators
Galderma R&D
Responsible party
David J. Goldberg, MD (Principal Investigator, Skin Laser & Surgery Specialists) — Principal investigator
First posted
Apr 26, 2018
Start date
Sep 27, 2016
Primary completion
Sep 20, 2017
Completion
Sep 20, 2017
Last update
Apr 18, 2023
View the source record on ClinicalTrials.gov ↗

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