None listed
Conditions
Interventions
Intervention1: Proveda Pain Cream: Leave on Product applied topically once on Day 1 and left for 24 hours and removed. The skin is assessed for any irritation for 9 days.
Control Intervention1: Negati
Sponsors
ProVEDA Corporation
Eligibility
Inclusion criteria
Inclusion criteria: Voluntary men and women ratio of 1:1 between 18 and 65 years Having apparently healthy skin on test area as assessed by dermatological examination For whom the investigator considers that the compliance will be correct Subjects with normal, dry, oily and combination skin in approximately equal ratio Subjects cooperating is informed of the need and duration of the examination and ready to comply with protocol procedures Having a signed consent form Subjects willingness to avoid intense UV exposure on test site (sun or artificial UV) during the study Willingness to avoid excessive water contact (eg swimming) or activity which causes excessive sweating (eg exercise, sauna) during the study Having valid proof of identity and age Volunteers evaluated with Fitzpatrick skin type 3 to 5 as per the Fitzpatrick scale.
Exclusion criteria
Exclusion criteria: Pregnant or nursing mothers Scars, acne, excessive terminal hair, or tattoo on the studied area Dermatological infection or pathology on level of studied area Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures Chronic illness which may influence the outcome of the study Subjects on any medical treatment either systemic or topical which may interfere with the performance of the study treatment (presently or in the past 1 month) Subject in an exclusion period or participating in another food, cosmetic, or therapeutic trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of mean irritation score of the test product from baseline to post application, 0 hours (30 minutes),24 hours and 168 hours post patch removal. Timepoint: Day 2, Day 3 and Day 9 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (safety and tolerability) after patch application, at 0 hrs (30 minutes), 24 hrs and 168 hrs post patch removalTimepoint: Day 1, Day 2, Day 3 and Day 9 | — |
Countries
India
Contacts
Public ContactMeena Dalal
TrialGuna Private Limited
Outcome results
None listed