Acne Vulgaris
Conditions
Brief summary
Percent change from Baseline to Week 12 in the facial inflammatory (papules and pustules) lesion count in each of the three treatment arms., Percent change from Baseline to Week 12 in the facial noninflammatory (open and closed comedones) lesion count in each of the three treatment arms.
Detailed description
Proportions of participants receiving Test and Reference product who have achieved a clinical response of 'success' to therapy at Week 12 according to the IGA scale., Incidence and severity of treatment-emergent serious and nonserious topical and systemic AEs and adverse drug reactions (ADRs) in each of the treatment arms during the 12-week study period., Proportions of participants with application site reactions (i.e., erythema, dryness, burning/stinging, erosion, edema, pain and itching), overall and per type and severity of reaction, in each of the treatment arms during the 12-week study period., Proportions of participants with permanent treatment discontinuations, and reasons for discontinuation in each of the treatment arms during the 12-week study period.
Interventions
DRUGClindamycin + tretinoin/Verisfield gel [10 mg/g (1%) clindamycin (as
clindamycin phosphate) + tretinoin 0.25 mg/g (0.025%) gel]
DRUGClindamycin +Tretinoin gel
DRUGAcnatac 10 mg/g + 0
DRUG25 mg/g γέλη
Sponsors
Verisfield Single Member S.A.
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from Baseline to Week 12 in the facial inflammatory (papules and pustules) lesion count in each of the three treatment arms., Percent change from Baseline to Week 12 in the facial noninflammatory (open and closed comedones) lesion count in each of the three treatment arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportions of participants receiving Test and Reference product who have achieved a clinical response of 'success' to therapy at Week 12 according to the IGA scale., Incidence and severity of treatment-emergent serious and nonserious topical and systemic AEs and adverse drug reactions (ADRs) in each of the treatment arms during the 12-week study period., Proportions of participants with application site reactions (i.e., erythema, dryness, burning/stinging, erosion, edema, pain and itching), overall and per type and severity of reaction, in each of the treatment arms during the 12-week study period., Proportions of participants with permanent treatment discontinuations, and reasons for discontinuation in each of the treatment arms during the 12-week study period. | — |
Countries
Greece
Outcome results
None listed