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Tetracycline Antibiotic

Sarecycline for Perioral Dermatitis

Phase 4
Waitlist Available
Research Sponsored by The Dermatology Institute of Boston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is male or female, 18-55 years of age inclusive at Screening.
Be between 18 and 65 years old
Must not have
Immunocompromised
Ongoing use of any of the following treatments to the face throughout study: oral or topical steroids, oral or topical calcineurin inhibitors, topical retinoids, topical antibiotics, oral or topical metronidazole, or topical azelaic acid
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial tested a new medication called Sarecycline to see if it is effective, safe, and well-tolerated for treating Periorificial Dermatitis in a small group of patients at one

Who is the study for?
This trial is for adults aged 18-55 with a confirmed diagnosis of Periorificial Dermatitis (POD) and a PODSI score of at least 3.0. Participants must not have difficulty swallowing, be pregnant or lactating, use certain facial treatments, or have allergies to tetracyclines.
What is being tested?
The study is testing the effectiveness, safety, and tolerability of an oral medication called Sarecycline in treating Periorificial Dermatitis. It's conducted at a single center where participants will receive this treatment.
What are the potential side effects?
While specific side effects for Sarecycline in this trial are not listed, common ones may include nausea, vomiting, sun sensitivity, teeth discoloration in children and changes in gut flora leading to stomach upset.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 55 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My immune system is weak.
Select...
I am currently using medication on my face such as steroids or antibiotics.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
PODSI score

Side effects data

From 2020 Phase 4 trial • 100 Patients • NCT04555525
3%
headache
1%
influenza
1%
metallic taste
1%
ingrown eyebrow hair
1%
r ear infection
1%
nausea
1%
generalized muscle soreness
1%
herpes simplex l lower lip
1%
intermittent pain under r rib cage
1%
Boil
1%
bone spur
1%
cholecystectomy
1%
cholelithiasis worsening
1%
dry lips
1%
facial sunburn
1%
dog bite r arm
1%
gastroenteritis
1%
rash of unknown origin
1%
respiratory syncytial virus
1%
sinus infection
1%
sleep apnea
1%
stomach bloating
1%
sunburn on face
1%
tinea versicolor
100%
80%
60%
40%
20%
0%
Study treatment Arm
Sarecycline
Centrum Adult Multivitamin

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: A Single-ARM Pilot Study to Evaluate Sarecycline for Treating Periorificial DermatitisExperimental Treatment1 Intervention
A Single-Center Pilot Study to Evaluate the Efficacy, Safety, and Tolerability of Sarecycline for Treating Periorificial Dermatitis
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Seysara Oral Product
2023
Completed Phase 4
~10

Find a Location

Who is running the clinical trial?

The Dermatology Institute of BostonLead Sponsor
~4 spots leftby Oct 2025
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