CTRI/2025/09/094644
Not yet recruiting
Post Marketing Surveillance
A Clinical Study to Evaluate the moisturization potential of Deep Revitalise Balanced Barrier Creme- Sensitive skin
Honasa Consumer Limited1 site in 1 country32 target enrollmentStarted: September 23, 2025
Overview
- Phase
- Post Marketing Surveillance
- Status
- Not yet recruiting
- Sponsor
- Honasa Consumer Limited
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- 1. Change in Hydration
Overview
Brief Summary
A single blind one arm study.
Each participant entering the trial will be assigned to a regimen of investigational product at marked Test product box and no product at the other box.
Assessment Time:
(Day 0 (T0min, T+30 mins)
Day 1 and Day 7)
Assessments:
-
Skin Hydration with Corneometer (Day 0 (T0min, T+30 mins) Day 1 and Day 7)
-
TEWL with Tewameter (Day 0 (T0min, T+30 mins) and Day 7)
-
IR imaging and sensitivity Score (0-4) (Day 0 (T0min, T+30 )
-
Erythema Index with Mexameter- redness (Day 0 and Day 7)
Study Design
- Study Type
- Pms
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 20.00 Year(s) to 35.00 Year(s) (—)
Inclusion Criteria
- •Gender: Male or Female with age 20-
- •Subjects willing to give written informed consent 4) Women of child bearing potential must have a negative urine pregnancy test prior to study entry.
- •Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events.
- •Are willing to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural or artificial) for the duration of the study.
Exclusion Criteria
- •Subjects who are pregnant, breast-feeding, or planning to become pregnant during the study.
- •Have any evidence of systemic cancer, squamous cell carcinoma, basal cell carcinoma, in the last 5 years, or any other confounding skin condition.
- •Have open sores or open lesions in the treatment area(s).
- •Have any condition that, in the opinion of the investigator, would confound the safety and efficacy assessments of the product.
- •Have participated in any interventional clinical trial in the previous 90 days.
- •Have a known sensitivity to any of the constituents of the test product.
- •Have used, are using, or are planning to use immunosuppressive or immunomodulatory medication (i.e.,biologics), including corticosteroids.
- •Have not skin related issues.
Outcomes
Primary Outcomes
1. Change in Hydration
Time Frame: At T0min, T30min, T1 day and T7 Days
2. Change in TEWL
Time Frame: At T0min, T30min, T1 day and T7 Days
3. IR ianging
Time Frame: At T0min, T30min, T1 day and T7 Days
Secondary Outcomes
- Not Applicable(Not Applicable)
Investigators
Dr Robin Chugh
CCFT Laboratories
Study Sites (1)
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