CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 100 enrolled
Drug / intervention
sarecycline +1 moredrug
Likely dose
Sarecycline tablet (exact dose not specified)AI-extracted
Key inclusion· 6
  • Age ≥18 years
  • Moderate to severe rosacea (IGA score 3 or 4)
  • 15–50 facial papules and pustules, excluding lesions on eyes and scalp
  • No more than 2 nodules on the face
Key exclusion· 11
  • Pregnant, lactating, or planning pregnancy during study
  • Hypersensitivity or allergy to tetracyclines or formulation components
  • History of C. difficile–associated colitis or intracranial hypertension
  • Moderate or severe rhinophyma, dense telangiectasia, or plaque-like facial edema

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04555525
NCT04555525Phase 4Completed

A Pilot Study on the Use of Seysara for Rosacea

Derm Research, PLLC·interventional·Posted Sep 18, 2020·Updated Jan 7, 2021

In Brief

A Phase 4 clinical trial evaluating sarecycline and Centrum Adult Multivitamin for Acne Rosacea. Completed, enrolled 100 participants across 1 site.

Detailed 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.)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcne Rosacea
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedSep 18, 2020
Enrollment StartApr 15, 2019
Primary CompletionSep 23, 2020
Study CompletionOct 1, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 5.8 years ago

Interventions

sarecyclinedrug

sarecycline tablet

Centrum Adult Multivitamindietary

Centrum Adult Mulltivitamin tablet