Profiling the Skin Microbiome in Response to Altreno in Acne Patients

• ClinicalTrials.gov Identifier: NCT04548349
• Recruitment Status: Active, not recruiting
• First Posted: September 14, 2020
• Last Update Posted: December 16, 2022
• Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: Ortho Dermatologics
• Information provided by (Responsible Party): Jean S. McGee, MD, PhD, Beth Israel Deaconess Medical Center

Study Description

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.

Study Design

• 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
• Actual Study Start Date: April 23, 2021
• Estimated Primary Completion Date: February 22, 2023
• Estimated Study Completion Date: March 31, 2023

Arms and Interventions

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.

Outcome Measures

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 ]

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, Massachusetts

Beth Israel Deacones Medical Center

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

Ortho Dermatologics

More Information

Publications:

Chien AL, Tsai J, Leung S, Mongodin EF, Nelson AM, Kang S, Garza LA. Association of Systemic Antibiotic Treatment of Acne With Skin Microbiota Characteristics. JAMA Dermatol. 2019 Apr 1;155(4):425-434. doi: 10.1001/jamadermatol.2018.5221.

Kelhala HL, Aho VTE, Fyhrquist N, Pereira PAB, Kubin ME, Paulin L, Palatsi R, Auvinen P, Tasanen K, Lauerma A. Isotretinoin and lymecycline treatments modify the skin microbiota in acne. Exp Dermatol. 2018 Jan;27(1):30-36. doi: 10.1111/exd.13397. Epub 2017 Sep 14.

• Responsible Party: Jean S. McGee, MD, PhD, Assistant Professor of Dermatology, Beth Israel Deaconess Medical Center
• ClinicalTrials.gov Identifier: NCT04548349
• Other Study ID Numbers: 2020P000595
• First Posted: September 14, 2020
• Last Update Posted: December 16, 2022
• Last Verified: December 2022

• 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:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Benzoyl Peroxide; Dermatologic Agents