PHARMACEUTICAL STUDIES

 

  • Prescription drugs (RX drugs)
  • Over-the-Counter drugs (Consumer Health Care)
  • Generic drugs

PHASE 1 STUDIES

1.  Skin safety and Photosafety Testing (Standard)


  • Cumulative Skin Irritancy Studies

           

           Repeated Patch Tests. Sample size: 50.

           Study Duration : 3 weeks.


  • Contact Sensitization Studies

 

           Repeated Patch Tests. Sample size: 200.

           Study duration/subject: 6 weeks.

       

  • Phototoxicity Potential

 

           Single application (patch)/ UV exposure.

           Sample size: 50.

           Study duration/subject: 5 days.

 

  • Photosensitization Potential (Photoallergy)

 

          Repeated Patch Tests/ UV exposures.

          Sample size: 50.

          Study duration/subject: 6 weeks.


2. Skin Safety Tests (Maximized or Special Tests)

  • Kligman Human Maximization Test (abraded skin)
  • Soap Chamber Test
  • Flex Wash Test (Repeated Application Open Test)
  • Acneigenicity or Comedogenity Tests
  • Atrophogenic Potential

 

3. Dermatopharmacokinetics/Bioequivalence Studies

  • Tape Strippings

            Impaired Skin Barrier,

            Corneocytes Collection

            Active Quantification

 


  • Suction Blisters

 

          In vivo epidermis/dermis atraumatic separation.

 

  • Full Skin Biopsies
  • Biologic Fluids Collection

 

 

Clinical Operations Manager Magali PROCACCI-BABLED

Phase 2a Studies

PROOFS OF CONCEPT

 

Multiple intra-individual comparisons

 

Examples:

ž   Dumas-Scholtz test (Plaque Psoriasis). Expert skill

ž   Contact dermatitis inhibition test

ž   UV-induced erythema or pain inhibition test

ž   Alopecia hair growth study (Mini-zone phototrichogramme)

 

Intra-individual comparison “Right-left”

 

Examples:

ž   Facial acne

ž   Atopic dermatitis

ž   Psoriasis

ž   Melasma

 

 

PHARMACODYNAMIC TESTS

 

Examples:

ž   Vasoconstrictor test in healthy skin (McKenzie-Stoughton) Expert skill

ž   Classification of dermocorticoids (Ranking test), EU or US methodology on request

ž   Bioequivalence of generic corticoids, EU/US regulatory methodology

ž   Contact urticaria (non-steroidal anti-inflammatories) Published methodology (CPCAD, Luc Duteil)

ž   Neurogenic inflammation test (capsaicin induction)

ž   Mini-zone induced pruritus or provoked pain inhibition test