souseikai global clinical research center

Dermatological Studies

As of December 2019, we have conducted 163 External preparation studies (60 Systemic & 103 topical).

Preparations of the investigational transdermal agents that we have conducted include Ointments, Creams, Gels, Lotions, Liquid, Adhesive Preparations, Tape, Plasters, Cataplasm, Shampoo, and Microneedle Patches.



We have conducted many studies involving patch tests (single, multiple) for topical and adhesive preparations in order to assess their skin-irritating nature in accordance with both ICDRG (International Contact Dermatitis Research Group) and Japanese Guidelines. We also are able to conduct photo patch tests using UVA and UVB.

One of our expertise is in the study of patients with atopic dermatitis. Depending on the client's needs, we can use SCORAD (Severity Scoring of Atopic Dermatitis), and EASI (Eczema Area and Severity Index), as well as the Japanese Society of Dermatology severity categories for evaluations.

Special Evaluations

  • Dermatopharmacokinetics (DPK)
  • Bacterial harvest and culture for skin antiseptic agent tests
  • Vasoconstrictive capacity, vasodilatory effects
  • PK/PD of the DDS preparations in all therapeutic areas
  • Adhesion tests
  • Residual drug collection
  • Prick test
  • Patch test
  • Pin Prick test
  • Punch Biopsy


Subjects

  • Healthy Japanese Male/Female
  • Healthy Caucasian Male/Female
  • Healthy Korean Male
  • Healthy Chinese Male
  • Atopic Dermatitis Patients
  • Psoriasis Patients
  • Acne Vulgaris Patients
  • Alopecia Patients (Androgenetic, premature)
  • Axillary Hyperhidrosis Patients
  • Tinea Unguium Patients