A Randomized, Double-Blind, Placebo Controlled, Multi-center Study to Evaluate the Safety and Efficacy of FB102 in Patients with Non-Segmental Vitiligo.
Approximately 64 participants who meet all the screening eligibility criteria will be randomized to receive FB102 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Skin & Cancer Foundation Australia - The Skin Hospital
Darlinghurst, New South Wales, Australia
RECRUITINGNovatrials
Kotara, New South Wales, Australia
RECRUITINGCornerstone Dermatology
Coorparoo, Queensland, Australia
Number of participants with treatment-emergent adverse events (TEAEs) and Serious Adverse events (SAE) following treatment with FB102
Time frame: Upto 16 Weeks post first dose administration
Percent change from Baseline in central read facial-vitiligo area scoring index (F-VASI)
The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study
Time frame: Upto 16 Weeks post first dose administration
Number of participants with percent change from Baseline in central read facial-vitiligo area scoring index (F-VASI)
The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study
Time frame: Upto 16 Weeks post first dose administration
Proportion of participants achieving by percent change improvement in central read F-VASI from Baseline.
The VASI Score is used to assess the severity and extent of Vitilgo. F-VASI is calculated using a formula that includes involvement of the face (possible range, 0-4), with percentage of vitiligo involvement estimated in finger units by the same investigator throughout the study
Time frame: Upto 16 Weeks post first dose administration
To evaluate the efficacy of FB102 compared to placebo by percent change from Baseline in total-Vitiligo Area Scoring Index (T-VASI)
T-VASI is calculated using a formula that includes contributions from all body regions (possible range, 0-100). The body is divided into 6 separate and mutually exclusive sites (head/neck, hands, upper extremities \[excluding hands\], trunk, lower extremities \[excluding feet\], and feet), with percentage of vitiligo involvement estimated in hand units by the same investigator throughout the study
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Optimal Clinical Trials North
Auckland, Auckland, New Zealand
RECRUITINGOptimal Clinical Trials Central
Auckland, Auckland, New Zealand
RECRUITINGMomentum Pukehoke
Auckland, Auckland, New Zealand
RECRUITINGTime frame: Upto 16 Weeks post first dose administration