A Pilot Study on the Use of Seysara for Rosacea

NCT04555525 | Completed Phase 4 Results FDA Drug

• 1 other identifier: SEY1901
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• 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)

  12 weeks

• Inflammatory Lesion Count

  Change in inflammatory lesion count

  Baseline and 12 weeks

Secondary Outcomes (4)

• IGA

  week 4

• IGA

  week 8

• Inflammatory Lesion Count

  Baseline and Week 4

• Inflammatory Lesion Count

  Baseline and Week 8

Study Arms (2)

sarecycline

EXPERIMENTAL

weight-based dose per label by mouth once daily for 12 weeks

Drug: sarecycline

Centrum Adult Multivitamin

OTHER

one tablet by mouth daily for 12 weeks

Dietary Supplement: Centrum Adult Multivitamin

Interventions

sarecycline DRUG

sarecycline tablet

Also known as: Seysara, sarecycline hydrochloride

sarecycline

Centrum Adult Multivitamin DIETARY_SUPPLEMENT

Centrum Adult Mulltivitamin tablet

Centrum Adult Multivitamin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 -

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Derm Research, PLLC: lead

Study Sites (1)

Skin Sciences, PLLC

Louisville, Kentucky, 40217, United States

Location

MeSH Terms

Conditions

Rosacea

Interventions

sarecycline

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Senen Pena
• Organization: Skin Sciences, PLLC

spdermresearch@yahoo.com

502-451-9000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director

Study Record Dates

• First Submitted: September 14, 2020
• First Posted: September 18, 2020
• Study Start: April 15, 2019
• Primary Completion: September 23, 2020
• Study Completion: October 1, 2020
• Last Updated: January 7, 2021
• Results First Posted: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)