This 4-arm Phase 2 vehicle-controlled study is designed to assess the safety and efficacy of PDI-320, and the individual components, in adult subjects with rosacea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Therapeutics Clinical Research
San Diego, California, United States
Academic Dermatology Associates
Albuquerque, New Mexico, United States
Treatment "Success Rate" based on change in Investigator's Global Assessment (IGA)
IGA Score Success Rate is defined as the percentage of subjects who achieve "Clear" (score = 0) or "Almost Clear" (score = 1) and have at least a 2-grade improvement on the IGA score at the End of Treatment. IGA score is used to evaluate the overall severity of rosacea using a 5-point scale from 0 (clear) to 4 (severe).
Time frame: Baseline and End of Treatment (up to 12 weeks)
Absolute change in inflammatory lesion count
Inflammatory lesions include papules and pustules on the face, and are counted by study personnel.
Time frame: Baseline and End of Treatment (up to 12 weeks)
Treatment "Success Rate" based on change in IGA (interim time points)
IGA Score Success Rate is the same as defined in the Primary Outcome Measures.
Time frame: Baseline, Week 4 and Week 8
Absolute change in inflammatory lesion count (interim time points)
Inflammatory lesions include papules and pustules on the face, and are counted by study personnel.
Time frame: Baseline, Week 4 and Week 8
Change in erythema severity
The investigator will assess the erythema (skin redness) on the entire face, using a grading scale from 0 (none) to 4 (very severe)
Time frame: Baseline and End of Treatment (up to 12 weeks)
Change in telangiectasia severity
The investigator will assess telangiectasia (small dilated blood vessels near the surface of the skin) on the face, using a grading scale of 0 (none) to 3 (severe).
Time frame: Baseline and End of Treatment (up to 12 weeks)
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