A Study of the Safety, Engraftment, and Action of NB01 in Adults With Moderate Acne
NCT ID: NCT03450369
Last Updated: 2020-08-03
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE1
Total Enrollment
10 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-01-24
Study Completion Date
2018-06-18
Brief Summary
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Acne vulgaris is a multifactorial disease caused by overgrowth of Propionibacterium acnes (P. acnes), impaction of hair follicles, excessive sebum production and hormonal dysregulation. Recent literature from the Human Microbiome Project has shown there are unique microbial signatures specific to healthy and acne disease states.
From this data, the investigators hypothesize that by eliminating resident disease-associated bacterial strains and replacing them with health-associated strains, recurrences/fares of acne may be improved, mitigated, and prevented. Instead of current approaches which focus on eliminating all bacteria from the skin, the investigators aim to deliver healthy bacteria to restore the skin to a healthy state via this replacement therapy.
The investigators aim to test this in a Phase Ib single application study evaluating the safety, tolerability, and clinical impact that a single application of NB01, a live strain of P. acnes, has on adult subjects with moderate acne.
From this data, the investigators hypothesize that by eliminating resident disease-associated bacterial strains and replacing them with health-associated strains, recurrences/fares of acne may be improved, mitigated, and prevented. Instead of current approaches which focus on eliminating all bacteria from the skin, the investigators aim to deliver healthy bacteria to restore the skin to a healthy state via this replacement therapy.
The investigators aim to test this in a Phase Ib single application study evaluating the safety, tolerability, and clinical impact that a single application of NB01, a live strain of P. acnes, has on adult subjects with moderate acne.
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Detailed Description
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A Phase 1B Dose Escalating Study of the Safety, Short-Term Engraftment and Action of a Singly Applied NB01 in Adults with Moderate Acne
Acne vulgaris is a multifactorial disease caused by overgrowth of Propionibacterium acnes (P. acnes), impaction of hair follicles, excessive sebum production and hormonal dysregulation. Recent literature from the Human Microbiome Project has shown there are unique microbial signatures specific to healthy and acne disease states.
From this data, the investigators hypothesize that by eliminating resident disease-associated bacterial strains and replacing them with health-associated strains, recurrences/fares of acne may be improved, mitigated, and prevented. Instead of current approaches which focus on eliminating all bacteria from the skin, the investigators aim to deliver healthy bacteria to restore the skin to a healthy state via this replacement therapy.
The investigators aim to test this in a Phase Ib single application study evaluating the safety, tolerability, and clinical impact that a single application of NB01 has on adult subjects with moderate acne. Investigators will be profiling the change in microbiome over the course of therapy to determine if exogenously delivered bacteria can populate the skin (engraftment) and cause a shift in the microbiome safely and subsequently impact acne biomarkers that may correlate with clinical disease.
The investigators intend for this therapy to eventually be used in acne subjects with ages ranging from 13-40, and all disease severities as either monotherapy for mild to mild/moderate acne and as an adjuvant therapy for moderate to severe acne at all body sites, with special attention to facial involvement.
This approach is standard to acne therapy whereby mild disease will be treated with a monotherapy (i.e., topical Benzoyl peroxide \[BPO\]) and moderate/severe disease will be treated with various combinatory regimens (topical antibiotics, BPO, topical retinoids, oral antibiotics).
Primary Objectives:
1. To determine the safety profile and tolerability of a singly applied NB01
2. To define engraftment of a singly applied topical NB01.
3. Dose schedule determination based on engraftment
Secondary Objective: To evaluate clinical efficacy using FDA standards of acne clinical assessments, namely the Investigator Global Assessment (IGA) and acne lesion counts of a singly applied NB01.
Approximately 10 total male and female adult subjects combined with moderate, non-cyclical acne will be enrolled into the trial. Approximately five (5) subjects will be assigned to each dose schedule
This is a single topical application study of live bacteria for the study of acne in adult subjects.
Subject participation in the trial will range from 5 weeks to 2 months.
Acne vulgaris is a multifactorial disease caused by overgrowth of Propionibacterium acnes (P. acnes), impaction of hair follicles, excessive sebum production and hormonal dysregulation. Recent literature from the Human Microbiome Project has shown there are unique microbial signatures specific to healthy and acne disease states.
From this data, the investigators hypothesize that by eliminating resident disease-associated bacterial strains and replacing them with health-associated strains, recurrences/fares of acne may be improved, mitigated, and prevented. Instead of current approaches which focus on eliminating all bacteria from the skin, the investigators aim to deliver healthy bacteria to restore the skin to a healthy state via this replacement therapy.
The investigators aim to test this in a Phase Ib single application study evaluating the safety, tolerability, and clinical impact that a single application of NB01 has on adult subjects with moderate acne. Investigators will be profiling the change in microbiome over the course of therapy to determine if exogenously delivered bacteria can populate the skin (engraftment) and cause a shift in the microbiome safely and subsequently impact acne biomarkers that may correlate with clinical disease.
The investigators intend for this therapy to eventually be used in acne subjects with ages ranging from 13-40, and all disease severities as either monotherapy for mild to mild/moderate acne and as an adjuvant therapy for moderate to severe acne at all body sites, with special attention to facial involvement.
This approach is standard to acne therapy whereby mild disease will be treated with a monotherapy (i.e., topical Benzoyl peroxide \[BPO\]) and moderate/severe disease will be treated with various combinatory regimens (topical antibiotics, BPO, topical retinoids, oral antibiotics).
Primary Objectives:
1. To determine the safety profile and tolerability of a singly applied NB01
2. To define engraftment of a singly applied topical NB01.
3. Dose schedule determination based on engraftment
Secondary Objective: To evaluate clinical efficacy using FDA standards of acne clinical assessments, namely the Investigator Global Assessment (IGA) and acne lesion counts of a singly applied NB01.
Approximately 10 total male and female adult subjects combined with moderate, non-cyclical acne will be enrolled into the trial. Approximately five (5) subjects will be assigned to each dose schedule
This is a single topical application study of live bacteria for the study of acne in adult subjects.
Subject participation in the trial will range from 5 weeks to 2 months.
Conditions
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Acne Vulgaris
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Open label.
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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NB01
NB01 is a live probiotic containing a single strain of P. acnes, frozen, on a pad, in a single use pouch, for topical application.
Open label and dose escalation of a single application of NB01 to subjects with moderate acne, with approximately 5 subjects assigned to lower bound dose before escalation to upper bound dose.
Group Type
EXPERIMENTAL
NB01
Intervention Type
BIOLOGICAL
Use an existing therapy designed to kill existing facial bacterial followed by populating facial skin with a single application of NB01
Interventions
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NB01
Use an existing therapy designed to kill existing facial bacterial followed by populating facial skin with a single application of NB01
Intervention Type
BIOLOGICAL
Eligibility Criteria
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Inclusion Criteria
1. Ability to provide written informed e-consent.
2. Males and Females ages 18-40.
3. Acne severity: Moderate (Grade 3 on 5-point IGA scale and Moderate on an acne lesion count scale (Appendix B \[Section 12.2\], IGA and Lesion Count Acne Grading).
4. Acne treatment-free period (including topical or oral antibiotics, retinoids, laser therapy, topical dapsone, topical azelaic acid, facial peels, dermabrasion, sulfacetamide sulfur, and salicylic acid), of at least 3 weeks prior to e-consent (with the exception of BPO pre-treatment under this protocol).
5. Lesion count: A minimum of at least a total of 15 inflammatory lesions (papules plus pustules), with a minimum of 10 inflammatory lesions within the designated application area (cheek/nose).
6. Females with non-cyclical acne.
7. Females of childbearing potential willing to use adequate contraception (e.g., total abstinence, intrauterine device (IUD), barrier method with spermicide, surgical sterilization or surgically sterilized partner, Depo-Provera®, Norplant®, or NuvaRing® for the duration of the Screening Period and during study participation. All oral contraceptive and hormonal implants will need to have been initiated and on a stable dose for at least 3 months prior to the screening period. Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal; postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
8. Male participants willing to use an acceptable method of contraception (e.g., total abstinence, barrier methods with spermicide, surgical sterilization or surgically sterilized partner) during study participation.
2. Males and Females ages 18-40.
3. Acne severity: Moderate (Grade 3 on 5-point IGA scale and Moderate on an acne lesion count scale (Appendix B \[Section 12.2\], IGA and Lesion Count Acne Grading).
4. Acne treatment-free period (including topical or oral antibiotics, retinoids, laser therapy, topical dapsone, topical azelaic acid, facial peels, dermabrasion, sulfacetamide sulfur, and salicylic acid), of at least 3 weeks prior to e-consent (with the exception of BPO pre-treatment under this protocol).
5. Lesion count: A minimum of at least a total of 15 inflammatory lesions (papules plus pustules), with a minimum of 10 inflammatory lesions within the designated application area (cheek/nose).
6. Females with non-cyclical acne.
7. Females of childbearing potential willing to use adequate contraception (e.g., total abstinence, intrauterine device (IUD), barrier method with spermicide, surgical sterilization or surgically sterilized partner, Depo-Provera®, Norplant®, or NuvaRing® for the duration of the Screening Period and during study participation. All oral contraceptive and hormonal implants will need to have been initiated and on a stable dose for at least 3 months prior to the screening period. Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or postmenopausal; postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause.
8. Male participants willing to use an acceptable method of contraception (e.g., total abstinence, barrier methods with spermicide, surgical sterilization or surgically sterilized partner) during study participation.
Exclusion Criteria
1. Active bacterial, viral, or fungal skin infections.
2. Any noticeable breaks or cracks in the skin on the face, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection.
3. Comorbid skin conditions in the area of application.
4. Active periodontal disease or ongoing procedures (e.g., gum grafting).
5. History/current ocular infections/surgeries within 6 months of enrollment, with the exception of any history of cataracts.
6. History of sarcoidosis.
7. History septic joints/endocarditis.
8. Participants with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier.
9. Sensitivity to or difficulty tolerating glycerin, polyethylene glycol.
10. History of isotretinoin use, with the exception of sub-therapeutic treatment within 8 weeks of enrollment.
11. Less than 80% compliance with BPO, or less than 5 days' worth of BPO pre-treatment (whichever is greater) during the Screening period.
12. Current major systemic comorbid conditions.
13. Currently participating in (or within 8 weeks of enrollment) another acne trial or other investigational drug.
14. Participants with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices/implantable devices/hardware.
15. Participants with close contact (e.g., spouses, children, or members in the same household) with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices/implantable devices/hardware.
16. Known chronic human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infections.
17. History of malignancy (with the exception of non-melanoma skin cancer).
18. Immunosuppression (such as resulting from transplantation, immunosuppressive therapy, active HIV infection/acquired immune deficiency syndrome \[AIDS\], neutropenia).
19. Major surgical procedure, open biopsy, or significant traumatic injury within 14 days of initiating study drug (unless the wound has healed), or anticipation of the need for major surgery during the study.
20. The presence of a medical or psychiatric condition, history of drug or alcohol abuse that, in the opinion of the PI, makes the subject inappropriate for study inclusion.
21. Participants with close contacts (e.g., spouses, children, or members in the same household) that have severe barrier defects or are immunocompromised.
22. Inability or unwillingness of participant to comply with study protocol procedures.
23. Pregnant or lactating females, or females who desire to become pregnant and/or breast feed within the duration of study participation.
24. Imprisonment or under legal guardianship.
2. Any noticeable breaks or cracks in the skin on the face, including severely excoriated skin or skin with open or weeping wounds suggestive of an active infection or increased susceptibility to infection.
3. Comorbid skin conditions in the area of application.
4. Active periodontal disease or ongoing procedures (e.g., gum grafting).
5. History/current ocular infections/surgeries within 6 months of enrollment, with the exception of any history of cataracts.
6. History of sarcoidosis.
7. History septic joints/endocarditis.
8. Participants with Netherton's syndrome or other genodermatoses that result in a defective epidermal barrier.
9. Sensitivity to or difficulty tolerating glycerin, polyethylene glycol.
10. History of isotretinoin use, with the exception of sub-therapeutic treatment within 8 weeks of enrollment.
11. Less than 80% compliance with BPO, or less than 5 days' worth of BPO pre-treatment (whichever is greater) during the Screening period.
12. Current major systemic comorbid conditions.
13. Currently participating in (or within 8 weeks of enrollment) another acne trial or other investigational drug.
14. Participants with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices/implantable devices/hardware.
15. Participants with close contact (e.g., spouses, children, or members in the same household) with prosthetic heart valves, pacemakers, intravascular catheters, or other foreign or prosthetic devices/implantable devices/hardware.
16. Known chronic human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infections.
17. History of malignancy (with the exception of non-melanoma skin cancer).
18. Immunosuppression (such as resulting from transplantation, immunosuppressive therapy, active HIV infection/acquired immune deficiency syndrome \[AIDS\], neutropenia).
19. Major surgical procedure, open biopsy, or significant traumatic injury within 14 days of initiating study drug (unless the wound has healed), or anticipation of the need for major surgery during the study.
20. The presence of a medical or psychiatric condition, history of drug or alcohol abuse that, in the opinion of the PI, makes the subject inappropriate for study inclusion.
21. Participants with close contacts (e.g., spouses, children, or members in the same household) that have severe barrier defects or are immunocompromised.
22. Inability or unwillingness of participant to comply with study protocol procedures.
23. Pregnant or lactating females, or females who desire to become pregnant and/or breast feed within the duration of study participation.
24. Imprisonment or under legal guardianship.
Minimum Eligible Age
18 Years
Maximum Eligible Age
40 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Dermatology Research Institute
OTHER
Sponsor Role
collaborator
QST Consultations, Ltd.
INDUSTRY
Sponsor Role
collaborator
Science 37
INDUSTRY
Sponsor Role
collaborator
Naked Biome, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Emma Taylor, MD
Role: STUDY_DIRECTOR
CEO
Locations
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Dermatology Research Associates
Los Angeles, California, United States
Site Status
Countries
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United States
References
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Achermann Y, Goldstein EJ, Coenye T, Shirtliff ME. Propionibacterium acnes: from commensal to opportunistic biofilm-associated implant pathogen. Clin Microbiol Rev. 2014 Jul;27(3):419-40. doi: 10.1128/CMR.00092-13.
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Akaza N, Akamatsu H, Numata S, Yamada S, Yagami A, Nakata S, Matsunaga K. Microorganisms inhabiting follicular contents of facial acne are not only Propionibacterium but also Malassezia spp. J Dermatol. 2016 Aug;43(8):906-11. doi: 10.1111/1346-8138.13245. Epub 2015 Dec 24.
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BACKGROUND
Baquerizo Nole KL, Yim E, Keri JE. Probiotics and prebiotics in dermatology. J Am Acad Dermatol. 2014 Oct;71(4):814-21. doi: 10.1016/j.jaad.2014.04.050. Epub 2014 Jun 4.
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Dailey HA, Gerdes S, Dailey TA, Burch JS, Phillips JD. Noncanonical coproporphyrin-dependent bacterial heme biosynthesis pathway that does not use protoporphyrin. Proc Natl Acad Sci U S A. 2015 Feb 17;112(7):2210-5. doi: 10.1073/pnas.1416285112. Epub 2015 Feb 2.
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Fitz-Gibbon S, Tomida S, Chiu BH, Nguyen L, Du C, Liu M, Elashoff D, Erfe MC, Loncaric A, Kim J, Modlin RL, Miller JF, Sodergren E, Craft N, Weinstock GM, Li H. Propionibacterium acnes strain populations in the human skin microbiome associated with acne. J Invest Dermatol. 2013 Sep;133(9):2152-60. doi: 10.1038/jid.2013.21. Epub 2013 Jan 21.
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Gribbon EM, Cunliffe WJ, Holland KT. Interaction of Propionibacterium acnes with skin lipids in vitro. J Gen Microbiol. 1993 Aug;139(8):1745-51. doi: 10.1099/00221287-139-8-1745.
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Johnson T, Kang D, Barnard E, Li H. Strain-Level Differences in Porphyrin Production and Regulation in Propionibacterium acnes Elucidate Disease Associations. mSphere. 2016 Feb 10;1(1):e00023-15. doi: 10.1128/mSphere.00023-15. eCollection 2016 Jan-Feb.
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Kang D, Shi B, Erfe MC, Craft N, Li H. Vitamin B12 modulates the transcriptome of the skin microbiota in acne pathogenesis. Sci Transl Med. 2015 Jun 24;7(293):293ra103. doi: 10.1126/scitranslmed.aab2009.
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Kasimatis G, Fitz-Gibbon S, Tomida S, Wong M, Li H. Analysis of complete genomes of Propionibacterium acnes reveals a novel plasmid and increased pseudogenes in an acne associated strain. Biomed Res Int. 2013;2013:918320. doi: 10.1155/2013/918320. Epub 2013 May 13.
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BACKGROUND
Kishishita M, Ushijima T, Ozaki Y, Ito Y. New medium for isolating propionibacteria and its application to assay of normal flora of human facial skin. Appl Environ Microbiol. 1980 Dec;40(6):1100-5. doi: 10.1128/aem.40.6.1100-1105.1980.
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BACKGROUND
Kjeldstad B, Johnsson A, Sandberg S. Influence of pH on porphyrin production in Propionibacterium acnes. Arch Dermatol Res. 1984;276(6):396-400. doi: 10.1007/BF00413361.
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BACKGROUND
Kwon HH, Suh DH. Recent progress in the research about Propionibacterium acnes strain diversity and acne: pathogen or bystander? Int J Dermatol. 2016 Nov;55(11):1196-1204. doi: 10.1111/ijd.13282.
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BACKGROUND
Lomholt HB, Kilian M. Population genetic analysis of Propionibacterium acnes identifies a subpopulation and epidemic clones associated with acne. PLoS One. 2010 Aug 19;5(8):e12277. doi: 10.1371/journal.pone.0012277.
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BACKGROUND
McDowell A, Barnard E, Nagy I, Gao A, Tomida S, Li H, Eady A, Cove J, Nord CE, Patrick S. An expanded multilocus sequence typing scheme for propionibacterium acnes: investigation of 'pathogenic', 'commensal' and antibiotic resistant strains. PLoS One. 2012;7(7):e41480. doi: 10.1371/journal.pone.0041480. Epub 2012 Jul 30.
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BACKGROUND
McDowell A, Nagy I, Magyari M, Barnard E, Patrick S. The opportunistic pathogen Propionibacterium acnes: insights into typing, human disease, clonal diversification and CAMP factor evolution. PLoS One. 2013 Sep 13;8(9):e70897. doi: 10.1371/journal.pone.0070897. eCollection 2013.
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BACKGROUND
McDowell A, Perry AL, Lambert PA, Patrick S. A new phylogenetic group of Propionibacterium acnes. J Med Microbiol. 2008 Feb;57(Pt 2):218-224. doi: 10.1099/jmm.0.47489-0.
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McGinley KJ, Webster GF, Ruggieri MR, Leyden JJ. Regional variations in density of cutaneous propionibacteria: correlation of Propionibacterium acnes populations with sebaceous secretion. J Clin Microbiol. 1980 Nov;12(5):672-5. doi: 10.1128/jcm.12.5.672-675.1980.
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Meyer K, Pappas A, Dunn K, Cula GO, Seo I, Ruvolo E, Batchvarova N. Evaluation of Seasonal Changes in Facial Skin With and Without Acne. J Drugs Dermatol. 2015 Jun;14(6):593-601.
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Mirshahpanah P, Maibach HI. Models in acnegenesis. Cutan Ocul Toxicol. 2007;26(3):195-202. doi: 10.1080/15569520701502815.
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Nakatsuji T, Chen TH, Narala S, Chun KA, Two AM, Yun T, Shafiq F, Kotol PF, Bouslimani A, Melnik AV, Latif H, Kim JN, Lockhart A, Artis K, David G, Taylor P, Streib J, Dorrestein PC, Grier A, Gill SR, Zengler K, Hata TR, Leung DY, Gallo RL. Antimicrobials from human skin commensal bacteria protect against Staphylococcus aureus and are deficient in atopic dermatitis. Sci Transl Med. 2017 Feb 22;9(378):eaah4680. doi: 10.1126/scitranslmed.aah4680.
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Sanchez A, Castro M, Castilla L, Guerrero P, Martin E. [Spontaneous peritonitis caused by Aeromonas hydrophila]. Enferm Infecc Microbiol Clin. 1989 Feb;7(2):112-3. No abstract available. Spanish.
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Richter C, Trojahn C, Dobos G, Blume-Peytavi U, Kottner J. Follicular fluorescence quantity to characterize acne severity: a validation study. Skin Res Technol. 2016 Nov;22(4):451-459. doi: 10.1111/srt.12286. Epub 2016 Jan 25.
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Shu M, Kuo S, Wang Y, Jiang Y, Liu YT, Gallo RL, Huang CM. Porphyrin metabolisms in human skin commensal Propionibacterium acnes bacteria: potential application to monitor human radiation risk. Curr Med Chem. 2013;20(4):562-8. doi: 10.2174/0929867311320040007.
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Thiboutot D, Gollnick H, Bettoli V, Dreno B, Kang S, Leyden JJ, Shalita AR, Lozada VT, Berson D, Finlay A, Goh CL, Herane MI, Kaminsky A, Kubba R, Layton A, Miyachi Y, Perez M, Martin JP, Ramos-E-Silva M, See JA, Shear N, Wolf J Jr; Global Alliance to Improve Outcomes in Acne. New insights into the management of acne: an update from the Global Alliance to Improve Outcomes in Acne group. J Am Acad Dermatol. 2009 May;60(5 Suppl):S1-50. doi: 10.1016/j.jaad.2009.01.019.
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Tomida S, Nguyen L, Chiu BH, Liu J, Sodergren E, Weinstock GM, Li H. Pan-genome and comparative genome analyses of propionibacterium acnes reveal its genomic diversity in the healthy and diseased human skin microbiome. mBio. 2013 Apr 30;4(3):e00003-13. doi: 10.1128/mBio.00003-13.
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BACKGROUND
Walsh TR, Efthimiou J, Dreno B. Systematic review of antibiotic resistance in acne: an increasing topical and oral threat. Lancet Infect Dis. 2016 Mar;16(3):e23-33. doi: 10.1016/S1473-3099(15)00527-7. Epub 2016 Feb 5.
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Wei EX, Kirsner RS, Eaglstein WH. End points in dermatologic clinical trials: A review for clinicians. J Am Acad Dermatol. 2016 Jul;75(1):203-9. doi: 10.1016/j.jaad.2016.01.052. Epub 2016 Feb 28.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
http://clinicaltrials.gov/ct2/show/NCT00964223
\[ClinicalTrials.gov\] Investigator Assessment Tolerability Scoring: A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne. Received: August 2009; Updated: October 2016.
http://www.dermnetnz.org/topics/acne-vulgaris
DermNet New Zealand. Acne vulgaris: Acne Grading
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM071292
\[FDA\] Guidance for Industry: Acne Vulgaris: Developing Drugs for Treatment. Draft: September 2005
http://clinicaltrials.gov/ct2/show/study/NCT00964223
Investigator Assessment Tolerability Scoring. A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne, 2009; updated 2016
http://www.surgicalcosmetic.org.br/detalhe-artigo/404
Propionibacterium acnes e a resistência bacteriana \[Propionibacterium acnes and bacterial resistance\]
http://www.springer.com/us/book/9780387950433
Propionibacteriales ord. Nov. In: Whitman W, et al. eds. Bergey's Manual of Systematic Bacteriology
Other Identifiers
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NB01-P1BSA
Identifier Type: -
Identifier Source: org_study_id
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Exploring Acne Treatments Through Clinical Research Participation
NCT07010458
NOT_YET_RECRUITING
Study Evaluating the Efficacy and Safety of Omnilux Clear on Mitigating Mild to Moderate Acne
NCT06936332
COMPLETED
NA
Comparison of Two Salicylic Acid Formulations
NCT00848744
COMPLETED
NA
Evaluation of the Role of Propionibacterium Acnes in the Inflammatory Lesions Associated With Acne Vulgaris
NCT01929057
COMPLETED
Assessment of Biological, Biometrological Parameters and Consumer Needs in Adult Subjects with Acne
NCT06841393
TERMINATED
NA
DMT310-009 Topical in the Treatment of Acne Vulgaris
NCT06090721
COMPLETED
PHASE3
DMT310-001 Topical in the Treatment of Acne Vulgaris
NCT03536637
COMPLETED
PHASE2
Study to Evaluate Safety, Efficacy and Immunogenicity of Acne mRNA Vaccine in Participants With Mild Acne
NCT07013747
RECRUITING
PHASE1/PHASE2
Clinical Study to Test the Efficacy and Safety of Adapalene, 0.1%
NCT00599521
COMPLETED
PHASE3
A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris
NCT02535871
UNKNOWN
PHASE3
Efficacy and Tolerance of Formula 609613 37 in Acneic Patients
NCT05469880
COMPLETED
NA