None listed
Conditions
Interventions
Intervention1: Facial Serum (ITC-AAS07-2021): 2-4 drops of serum will be applied Twice daily on Face for 28 days. Once at site on forearm
Control Intervention1: None: None
Sponsors
ITC Life Sciences Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.Indian/Asian female subjects 2.Healthy subjects between 18 and 35 years of age. 3.Skin in healthy on the studied anatomic site (free of eczema, wounds, cuts, bruises, inflammatory scar) 4.Subjects willing to abide by the study protocol and restriction (refrain from using any product other than provided investigational product (IP)). 5.Subjects with sensitive skin fairly in equal representation of varied skin types i.e. Dry, Normal, Oily & Combination Skin type in equal ratio. 6.Subjects who score greater than 30 for section 2- sensitive vs resistant skin in Dr. Baumannââ?¬•s questionnaire. 7.22 subjects with sensitive skin type with acne of mild severity as per global acne grading scale. 8.23 subjects with sensitive skin type with acne of moderate severity as per global acne grading scale. 9.Subjects who tolerate the IP well showing no sensitivity symptoms during sensitivity test. 10.Subjects who are willing to use the face serum and cleanser provided (and no other leave on moisturizer/serum) during the study duration. 11.Subjects will to visit the study centre for periodic assessment on the scheduled dates. 12.Subjects who have not participated in a similar investigation in the past eight weeks.
Exclusion criteria
Exclusion criteria: 1.Subjects who are pregnant or nursing (as confirmed by Urine pregnancy test for the determination of Pregnancy). 2.Subjects with a present condition of allergic response to any cosmetic product. 3.Subjects undergoing treatment for anti-acne or skin lightening. 4.Subjects under chronic medication (e.g. aspirin-based products, anti-inflammatories, anti-histamines etc.) that might influence the outcome of the study. 5.Subjects who has used any systemic medication (antibiotics, oral contraceptive pills, steroids, or any other anti-acne medication) or any topical facial medication with in past 4 weeks. 6.Having acne of severe incidence (presence of Nodules, Cysts or numerous pustules) which requires pharmaceutical treatment. 7.Subjects with excessive facial hair or scars, which could interfere with evaluation. 8.Subjects having cutaneous hypersensitivity. 9.Subjects participating in any other cosmetic or therapeutic trial. 10.Subjects having changed her cosmetic habits required as per protocol before the start of the study on the studied site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1 - To evaluate efficacy, safety and sensory evaluation of the test product in reducing acne over baseline. Part 2 - To evaluate and compare instant moisturization benefit at 5 min post single product application in comparison to baseline and untreated control. To determine the efficacy of the test product in providing deep moisturization benefit after tape stripping at 0, 3, 6, 10, 15 strips in comparison to baseline and untreated control Timepoint: Part 1 - Baseline, Immediate, Day 4, Day 8, Day 15 and Day 29 Part 2 - Baseline & Immediate | — |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 - To monitor the sensory and overall changes in skin condition upon usage of the test product in comparison to baseline. Part 2 - To evaluate the product safety and tolerance of the test product/s by dermatological assessment.Timepoint: Part 1 - Baseline, Immediate, Day 4, Day 8, Day 15 and Day 29 Part 2 - Baseline & Immediate | — |
Countries
India
Contacts
Public ContactDr Mukesh Ramnane
MS Clinical Research Pvt Ltd
Outcome results
None listed