Research Capabilities

Preclinical Services

Aeroscena can deliver a broad range of services ranging from preclinical testing to full clinical trial support. Below is a listing of the antifungal and dermatology services we provide:

Antimicrobial activity in vitro

  • Antifungal susceptibility testing (AST) CLSI and EUCAST based:
    • Minimum inhibitory concentration (MIC)
    • Minimum fungicidal concentration (MFC)
    • Minimum effective concentration (MEC
  • Testing of drug combinations
  • Time-kill assay (microbial kill curves)
  • Post-antimicrobial effect (PAE)
  • Nail penetration assay including lacquer effect on drug penetration 
  • Keratin binding assay
  • Biofilms prevention and treatment assays 

In vivo testing (small animals)

  • Immunocompetent and immunosuppressed models:
    • Mouse
      • Invasive candidiasis, Invasive mould infections (aspergillosis, fusariosis, mucormycosis), Mucosal (oral and vaginal) candidiasis, Wound infection model, Subcutaneous device-associated microbial biofilms, Keratitis (Fusarium, Candida, bacterial)
    • Guinea pig
      • Onychomycosis (topical and oral dosing), Invasive and cutaneous candidiasis
    • Rabbit
      • Invasive candidiasis, Biofilms-associated infections

Mechanism of Action (MOA)

  • Effect on microbial ultrastructure/morphology/architecture
  • Inhibition of cell wall synthesis/cell wall damange
  • Lysis of cell membrane
  • Protein synthesis
  • Inhibition of DNA or RNA replication
  • Assessment of potential to develop resistance

Clinical Services

  • Clinical trial support
  • Central lab for single and multi-site clinical trials both national and international 
  • Assist in selection of optimal clinical sites
  • Implementation of clinical protocols
  • Protocol-related training, Fungal isolate storage, Close interactions with site Principle Investigators (PI) and staff, Data integrity maintained in collaboration with other CROs

Assays performed

  • KOH/Fluorescent (Calcoflour) direct smear
  • Results sent within 24 hours
  • Culture and identification of fungi
  • Specimen-collection kits provided, Shipping material provided compliant with the International Air Transport Association (IATA)
  • Antifungal susceptibility testing
  • Baseline and end-of-study isolates that allows monitoring of resistance development

Data management

  • Comply with information technology rules/regulations
  • All data are firewall and password protected
  • Data stored in 21 CFR part 11-compliant database
  • Redundant data backup procedures in place

Regulatory services

  • Provides assistance with research design and regulatory compliance in accordance with IRB and federal requirements

 

Dermatology Services

  • Clinical trial support in the following areas:
    • Atopic Dermatitis
    • Autoimmune Responses
    • Cutaneous Lupus
    • Cutaneous Oncology
    • Hidradenitis
    • Laser Dermatology
    • Lymphoma
    • Melanoma and Skin Cancer
    • Psoriasis
    • Psoriatic Arthritis
    • Pyoderma Gangrenosum

Regulatory services

  • Provides assistance with research design and regulatory compliance in accordance with IRB and Federal requirements

Biological specimen acquisitions

  • Specifically skin biopsies in the form of punch, keratome, epidermal blister, stratum corneum stripping, as well as collection of blood, saliva and other specimens

In vivo assay and evaluations

  • Allergen sensitization/elicitation (patch testing), Transepidermal water loss measurements and chromametry

Clinical assessments

  • Clinical photography, utilization of skin scoring systems such as PASI, SCORAD and Scinexa

Phototesting and phototherapy

  • Specializes in phototesting with simulated solar radiation and erythema/pigmentation assessment using colorimetry

Skin, skin products and skin disease services

  • Sunscreens
  • Antioxidants
  • Probiotics
  • Hair Regrowth Agents
  • Allergy/Immune Response
  • Other interventions aimed at protecting or improving the condition of human skin, hair and nails