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Profiling the Skin Microbiome in Response to Altreno in Acne Patients

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ClinicalTrials.gov Identifier: NCT04548349
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : February 24, 2021
Sponsor:
Collaborator:
Ortho Dermatologics
Information provided by (Responsible Party):
Jean S. McGee, MD, PhD, Beth Israel Deaconess Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Acne Healthy Drug: Altreno Drug: Benzoyl peroxide Phase 4

Detailed Description:

With the advent of 16S rRNA sequencing, scientific community is beginning to understand the critical importance of the microbiome in human health. In dermatology, researchers have begun to lead the effort to not only better understand how the microbiome contributes to the pathogenesis of skin disease, but also harness its power to develop novel therapies. Acne is a common inflammatory skin disorder. P. acnes on the skin has been traditionally thought of as the culprit bacteria in the pathogenesis of acne.

Recent studies demonstrate that the skin microbial composition dynamically changes in response to systemic acne therapy. Using 16 rRNA gene sequencing, a prior study has confirmed that systemic antibiotic treatment decreased the abundance of P. acnes, which returned to baseline after discontinuation of the therapy. In contrast, the systemic therapy increased the abundance of Pseudomonas species, which returned to baseline after therapy cessation. Based on the opposing response to the therapy, it can be speculated that these two species compete for the same microenvironment within the skin microbiome. Interestingly, the same systemic therapy decreased the abundance of lactobacillus genus, the "good bacteria" that is protective against skin infection, and that decrease was sustained even after cessation of the therapy. Similarly, another study has demonstrated that systemic isotretinoin therapy disturbed the skin microbiome in acne patients with increased bacterial diversity on the cheeks. It is unclear the potential therapeutic role of the increased bacterial diversity in the management of acne patients.

The study aims to characterize the shift in the diversity and abundance of the skin microbial community in response to Altreno in acne patients. Understanding the role of the skin microbiome in response to therapy can help clinicians to develop tailored, targeted treatment options, including reconstitution of "good bacteria." Furthermore, it can lead to development of novel topical pre and probiotics.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Profiling the Skin Microbiome in Response to Altreno in Acne Patients
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

Arm Intervention/treatment
Experimental: Altreno Group Drug: Altreno
Acne patients will be assigned to Altreno once daily.

Experimental: BPO Group Drug: Benzoyl peroxide
Acne patients will be assigned to BPO leave-on gel once daily.

No Intervention: Control Group
During the entire study period, the subjects in the control group will not be allowed to use any antibacterial wash, other than approved OTC cleansers.



Primary Outcome Measures :
  1. Change in the diversity of the skin microbiome before and after the treatment with Altreno. [ Time Frame: Completion of study 120 days ]
    The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index of the bacterial DNA in the skin microbiome.

  2. Change in the diversity of the skin microbiome before and after the treatment with Altreno. [ Time Frame: Completion of study 120 days ]
    The diversity will be evaluated by assessing the Shannon diversity of the bacterial DNA in the skin microbiome.

  3. Change in the diversity of the skin microbiome before and after the treatment with BPO therapy. [ Time Frame: Completion of study 120 days ]
    The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index of the bacterial DNA in the skin microbiome.

  4. Change in the diversity of the skin microbiome before and after the treatment with BPO therapy. [ Time Frame: Completion of study 120 days ]
    The diversity will be evaluated by assessing the Shannon diversity of the bacterial DNA in the skin microbiome.


Secondary Outcome Measures :
  1. Change in Leeds score [ Time Frame: 120 days ]
    Score range is grade 1 to grade 12. Higher scores indicate a worse outcome

  2. Change in the lesion count of inflammatory and non-inflammatory [ Time Frame: 120 days ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548349


Contacts
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Contact: Principal Investigator 617-667-5201 jmcgee2@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deacones Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Dr. McGee         
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Ortho Dermatologics
Publications:
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Responsible Party: Jean S. McGee, MD, PhD, Assistant Professor of Dermatology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT04548349    
Other Study ID Numbers: 1234
First Posted: September 14, 2020    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Benzoyl Peroxide
Dermatologic Agents