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Acne RosaceaPhase 4NCT04555525

A Pilot Study on the Use of Seysara for Rosacea

A Phase 4 study testing sarecycline and Centrum Adult Multivitamin in people with Acne Rosacea, run by Derm Research, PLLC 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 prospective, parallel group, randomized, investigator-blinded pilot study. Approximately 100 subjects will be randomized at a 3:1 ratio to Seysara (sarecycline) at a weight-based dose per label or Centrum Adult Multivitamin to take by mouth daily. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Acne Rosacea
What is being tested?
sarecycline and Centrum Adult Multivitamin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
15 Apr 2019to 1 Oct 2020
Phase
Phase 4
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female ≥18 years of age
  • Moderate to severe rosacea (IGA score 3 or 4) on the proposed facial treatment area consisting of:
  • At least 15 and not more than 50 facial papules and pustules, excluding lesions involving the eyes and scalp
  • No more than 2 nodules on the face
  • Presence or history of erythema and/or flushing of the face
  • If a female of child-bearing potential, have a negative urine pregnancy test and agree to use an effective method of contraception. A sterile sexual partner is NOT considered an adequate form of birth control
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  • Willing to minimize external factors that might trigger rosacea flare-ups (eg, spicy foods, thermally hot foods and drinks, hot environments, prolonged sun exposure, strong winds, and alcoholic beverages
  • Subjects who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to use the same make-up, brand/type, or frequency of use throughout the study
  • Completed and signed an appropriately administered Informed Consent Form (ICF) prior to any study-related procedures -

Who cannot join

  • Woman who is pregnant, lactating, or planning to become pregnant during the study period
  • presence of any skin condition on the face that would interfere with the diagnosis or assessment of rosacea
  • Moderate or severe rhinophyma, dense telangiectasia (score 3, severe;) or plaque-like facial edema
  • Excessive facial hair (eg, beards, sideburns, moustaches, etc) that would interfere with diagnosis or assessment of rosacea
  • History of hypersensitivity or allergy to all tetracyclines, or to any other component of the formulation
  • Patients with history of C-diff associated colitis, intracranial hypertension will be excluded
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  • Severe erythema, dryness, scaling, pruritis, stinging/burning, or edema
  • Use within 6 months prior to Day 0/Baseline of oral retinoids (eg, Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed)
  • Initiation of use of estrogens or oral contraceptives less than 3 months prior to Day 0/Baseline
  • Use within 1 month prior to Day 0/Baseline of:
  • Systemic antibiotics known to have an impact on the severity of facial rosacea (eg, containing tetracycline and its derivatives, erythromycin and its derivatives, sulfamethoxazole, or trimethoprim.) Subjects requiring systemic antibiotics not known to affect rosacea will be considered on a case-by-case basis
  • Systemic corticosteroids (Note: intranasal and inhalational corticosteroids do not require a washout and maybe used throughout the trial if the subject is on a stable dose.)
  • Use within 2 weeks prior to Day 0/Baseline of:
  • Topical corticosteroids
  • Topical antibiotics
  • Topical medications for rosacea (eg, metronidazole)
  • Use of sauna during the 2 weeks prior to Day 0/Baseline and during the study
  • Had wax epilation of the face within 2 weeks prior to Day 0/Baseline
  • Active bacterial folliculitis
  • Consumption of excessive alcohol, abuse of licit or illicit drugs, or a condition that, in the opinion of the Investigator, could compromise the subject's ability to comply with study requirements
  • Participation in activities that involve excessive or prolonged exposure to sunlight or weather extremes, such as wind or cold
  • Presence of any clinically significant condition or situation, other than the condition being studied, that in the opinion of the Investigator would interfere with the study evaluations or optimal participation in the study
  • Participation in an investigational drug study (ie, subject has been treated with an investigational drug) within 30 days prior to Day 0/Baseline. Subjects who are participating in non-treatment studies such as observational studies or registry studies can be considered for inclusion
  • Prior laser therapy (for telangiectasia or other conditions), electrodessication, or phototherapy (eg, ClearLight ®) to the facial area within 180 days prior to Day 0/Baseline
  • Prior cosmetic procedures (eg, facials) that may affect the efficacy and safety profile of the investigational product within 14 days prior to Day 0/Baseline

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Skin Sciences, PLLC

    Louisville, Kentucky, 40217

Other trials in United States

About this study

This is a prospective, parallel group, randomized, investigator-blinded pilot study. Approximately 100 subjects will be randomized at a 3:1 ratio to Seysara (sarecycline) at a weight-based dose per label or Centrum Adult Multivitamin to take by mouth daily. The study is comprised of 5 visits: screening, baseline, week 4, week 8, and week 12. Investigators will perform rosacea IGA (Investigator Global Assessment,) inflammatory lesion count, record adverse events and con meds, and ask each subject to complete a DLQI (Dermatology Life Quality Index.)

Conditions
Acne Rosacea
Being tested
sarecycline, Centrum Adult Multivitamin
Medical subject headings
Rosacea

What participants receive

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

  • sarecyclineDrug

    Also called Seysara, sarecycline hydrochloride

    sarecycline tablet

  • Centrum Adult MultivitaminDietary supplement

    Centrum Adult Mulltivitamin tablet

Study groups in NCT04555525
Study groupRoleWhat they receive
sarecyclineExperimentalweight-based dose per label by mouth once daily for 12 weeks
Receives: Drug: sarecycline
Centrum Adult MultivitaminOtherone tablet by mouth daily for 12 weeks
Receives: Dietary Supplement: Centrum Adult Multivitamin

What is being measured

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

  1. IGA (Investigator Global Assessment)

    Percent of subjects achieving clear or almost clear on IGA. The Investigator will score rosacea at each visit as per the following IGA:

    0 = Clear (No inflammatory lesions present, no erythema); 1 = Almost Clear (Very few small papules/pustules, very mild erythema present); 2 Mild (Few small or large papules/pustules, moderate erythema); 3= Moderate (Several small or large papules/pustules, moderate erythema); 4 = Severe (Numerous small and/or large papules/pustules, severe erythema)

    Measured: 12 weeks

  2. Inflammatory Lesion Count

    Change in inflammatory lesion count

    Measured: Baseline and 12 weeks

Secondary outcomes (4)

  1. IGA

    Percent of subjects achieving clear or almost clear on IGA. The Investigator will score rosacea at each visit as per the following IGA:

    0 = Clear (No inflammatory lesions present, no erythema); 1 = Almost Clear (Very few small papules/pustules, very mild erythema present); 2 Mild (Few small or large papules/pustules, moderate erythema); 3= Moderate (Several small or large papules/pustules, moderate erythema); 4 = Severe (Numerous small and/or large papules/pustules, severe erythema)

    Measured: week 4

  2. IGA

    Percent of subjects achieving clear or almost clear on IGA. The Investigator will score rosacea at each visit as per the following IGA:

    0 = Clear (No inflammatory lesions present, no erythema); 1 = Almost Clear (Very few small papules/pustules, very mild erythema present); 2 Mild (Few small or large papules/pustules, moderate erythema); 3= Moderate (Several small or large papules/pustules, moderate erythema); 4 = Severe (Numerous small and/or large papules/pustules, severe erythema)

    Measured: week 8

  3. Inflammatory Lesion Count

    Change in inflammatory lesion count

    Measured: Baseline and Week 4

  4. Inflammatory Lesion Count

    Change in inflammatory lesion count

    Measured: Baseline and Week 8

Timeline

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

  1. First posted18 Sep 2020
  2. Study start15 Apr 2019
  3. Primary completion23 Sep 2020
  4. Study completion1 Oct 2020

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04555525
Sponsor's protocol ID
SEY1901
Status last verified
Dec 2020
First submitted
14 Sep 2020
Last updated
7 Jan 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sarecycline and Centrum Adult Multivitamin in people with Acne Rosacea, run by Derm Research, PLLC 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 9 inclusion and 25 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 7 Jan 2021. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 Dec 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?

IGA (Investigator Global Assessment) (time frame: 12 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 NCT04555525.

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 7 Jan 2021.

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