Dermatological Safety and Skin Compatibility Evaluation of Test Products
ConditionHealthy Subjects
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNovoBliss Research Pvt Ltd
About this trial
Dermatological Safety and Skin Compatibility Evaluation of Test Product following Cosmetics Europe: Product Test Guidelines for Assessment of Human Skin Compatibility (Colipa Standard, 1997)
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age: 18-65 years (both inclusive) at the time of consent.
Sex: Males and non-pregnant/non-lactating females (preferably equal number of males and females).
Subject with normal Fitzpatrick skin type III to VI (Human skin colour determination scale).
Females of childbearing potential must have a self-reported negative pregnancy test.
Disqualifiers
Subject having skin irritation, blemishes, excessive hair, moles, pigmentation, pimples, marks (e.g. tattoos (within the previous 3 months), scars, sunburn), open wounds, cuts, abrasions, irritation symptoms or any dermatological condition on the test site(s) i.e. back that can interfere with the reading.
Medication which may affect skin response and/or past medical history.
Subject having history of diabetes
Subject have history of mastectomy for cancer involving removal of lymph nodes within the past year, or treatment of any type of cancer within the last 6 months.
Trial design
Design model
Single group
Treatments tested in this trial
1.Bare Anatomy Expert Advanced Hair Growth Serum 2.Bare Anatomy Expert Ultra-Smoothing Shampoo 3.Bare Anatomy Expert Ultra-Smoothing Hair Serum 4.Bare Anatomy Expert Ultra-Smoothing Hair Mask
Other interventionDose: 0.1 ml of sample solution Route of administration: Topical Mode of usage: Products will be evaluated through the complete occlusion for 48 hours.
Treatment groups
26 Participants
are divided into 1 treatment groupGroup A: Single Arm includes 4 test products along with positive and negative controlExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the dermatological safety of the test products assessed by 48-hour patch test under complete occlusion condition.
Dermatological reactions will be evaluated using the 48-hour patch test method under complete occlusion. Assessments will be performed to detect any skin irritation, erythema, or other local reactions at the application site.
Time frame
30 ± 5 minutes post patch removal (Day 03), 24 ± 2 hours post patch removal (Day 04), and 48 ± 2 hours post patch removal (Day 05).Secondary outcomes
1
Skin Safety Evaluation by assessing Change in Transepidermal Water Loss (TEWL) at the Application Site
Transepidermal Water Loss (TEWL) at the site of product application will be measured using the TEWAMeter TM Hex to assess the impact of the investigational product on skin barrier function
Time frame
at baseline, 30 mins and 24 hours post patch removalLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NovoBliss Research Pvt Ltd
Lead sponsor
OneSto Labs Private Ltd.
Collaborator
Source ClinicalTrials.gov
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