An exploratory, prospective, open-label, randomized, three-arm, single-centre, safety, efficacy and in-use tolerability study of the three different test products in healthy adult human subjects with dry and sensitive skin. This exploratory, prospective, open-label, randomized, three-arm, single-centre, safety, efficacy and in-use tolerability study of the three different test products in healthy adult human subjects with dry and sensitive skin.
A total of up to 84 (28 subjects/arm) healthy male and non-pregnant \| non-lactating female with equal distribution of dry and sensitive skin (1:1) with an age of 18-55 years will be enrolled to complete the 75 subjects (25 subjects/arm) the study. The potential subjects will be screened as per the inclusion \& exclusion criteria only after obtaining written informed consent from the subjects. Subjects will be pre-screened by the screening department of NovoBliss Research. Subjects will be called telephonically by the recruiting department prior to the enrolment visit. Subjects will be told during screening (prior to enrolment) not to wear any facial make-up on the study visit day. Visit 01 (Day 01): Screening, Enrolment, Baseline Evaluation, On Site Product Usage, Post Usage Evaluation * Visit 02 (Day 08 +2 Days): Evaluations, Product usage period * Visit 03 (Day 30 +2 Days): Product Usage Period, Evaluations * Visit 04 (Day 60 +2 Days): Evaluations, End of Study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
84
Mode of Usage: After cleansing, apply liberally onto the skin and gently massage until fully absorbed. Manufactured By: Dermalogics Marketed By: Glowderma Lab Private Limited Frequency: Twice a Day Route of Administration: Topical
Mode of Usage: After cleansing, apply liberally onto the skin and gently massage until fully absorbed. Manufactured By: Dermalogics Marketed By: Glowderma Lab Private Limited Frequency: Twice a Day Route of Administration: Topical
Mode of Usage: After cleansing, apply liberally onto the skin and gently massage until fully absorbed. Manufactured By: Dermalogics Marketed By: Glowderma Lab Private Limited Frequency: Twice a Day or as often as needed Route of Administration: Topical
NovoBliss Research Pvt.Ltd
Ahmedabad, Gujarat, India
To evaluate the effectiveness of the test products in terms of change in skin hydration
Instrumental evaluation by Corneometer CM 825
Time frame: before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of the test products in terms of change in DASI score
Using DASI Score where 0 is absent 4 is extreme
Time frame: before usage of the test product on Day 01 and after usage of the test product at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of the test products in terms of change in overall dry skin score (ODS)
Using scoring scale where 0 is absent and 4 is extreme
Time frame: before usage of the test products on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of the test products in terms of change in PGA score
Scoring scale where 0 is none and 8 is extreme
Time frame: before usage of the test products on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of test products in terms of change in skin barrier function
Instrumental Evaluation by Tewameter TM Hex
Time frame: before usage of the test products on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of the test products in terms of change in skin roughness
Using Scoring Scale 0 is absent and 4 is extreme
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Time frame: before usage of the test products on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of the test products in terms of change in skin scaliness
Using Scoring Scale 0 is absent and 4 is extreme
Time frame: before usage of the test products on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of the test products in terms of change in skin smoothness
Using Scoring Scale 0 is absent and 4 is extreme
Time frame: before usage of the test products on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of the test products in terms of change in skin wrinkles
Using Scoring Scale 0 is absent and 4 is extreme
Time frame: before usage of the test products on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)
To assess the effectiveness of the test product in terms of change in desquamation index
using instrumental evaluation of VISIOSCAN VC 20 Plus though Corneofix® F 20
Time frame: before usage of the test products on Day 01 and after usage of the test products at T20 mins on Day 01, Day 08 (+2 Days), Day 30 (+2 Days) and Day 60 (+2 Days)