Phase 4
N=25
Profiling the Skin Microbiome in Response to Altreno in Acne Patients
Acne · Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04548349 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: CLR-transformed Abundance of Any Significant Taxa — 3.29; -2.49; -1.59; -2.75 Relative Abundance
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Altreno (Drug); Benzoyl peroxide (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Beth Israel Deaconess Medical Center
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CLR-transformed Abundance of Any Significant Taxa |
3.29; -2.49; -1.59; -2.75; -1.98 | — |
Summary
The study objective is to characterize the shift in the diversity and abundance of the skin microbial community at baseline and in response to Altreno monotherapy as compared to benzoyl peroxide (BPO) 2.5% leave-on gel monotherapy in acne patients.
Eligibility Criteria
Inclusion Criteria
- A confirmed diagnosis of acne that warrants initiating topical medications.
- Denies use of any prescribed systemic acne treatments in the past 30 days.
- Denies use of any prescribed topical medications in the past 30 days.
- Denies use of any OTC topical acne medications in the past 14 days.
- Denies use of any emollients in the past 24 hours (if feasible).
- Denies bathing or facial washing in the past 12 hours (if feasible).
- Willingness to adhere to the recommended topical regimen during the duration of the study.
Exclusion Criteria
- Women who are pregnant, breastfeeding, or planning to get pregnant during the study.
- Use of any investigational drug(s) in the past 3 months.
Data sourced from ClinicalTrials.gov (NCT04548349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.