CTRI/2025/05/087709Not yet recruitingNot Applicable
A Clinical Study to Evaluate the skin Senzitization potential of Babyhug Pro Sensitive pH 5.5 Peach Milk Cream on Healthy Huaman Volunteers
Brainbees Solutions Ltd1 site in 1 country210 target enrollmentStarted: July 6, 2025
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- Change in Skin Irritation Score-erythema & oedema
Study Overview
Brief Summary
210 human volunteers are selected for the patch test done as per BIS 4011 for sensitization
The experiment is 40 days including Induction phase: 21 days Rest Phase: 14 days Challenge Phase: 5 days.
Guideline Followed: BIS 4011: for skin sensitization
- Brainbees Babyhug Pro Sensitive pH 5.5 Peach Milk Cream
**Estimated time in study completion:**90-100 days.
· Screening Phase
· Induction Phase (21 DAYS) (24 hours after each patch removal)
· Rest Phase (14 DAYS)
Challenge Phase(5 days) (24 hours after the patch removal, 48 hours after patch removal and 72 hours after the patch removal)
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Voluntary man or women between 18 and 65 years.
- •Phototype III to V.
- •Having apparently healthy skin on test area.
- •For whom the investigator considers that the compliance will be correct.
- •Cooperating, informed of the need and duration of the examinations and ready to comply with protocol procedures.
- •Having signed a Consent Form.
- •Willingness to avoid intense UV exposure on test site (sun or artificial UV) during the course of the study.
- •Willingness to avoid excessive water contact (for example swimming) or activity which causes excessive sweating (that is exercise, sauna), during the course of the study.
- •Should be able to read and write (in English, Hindi or local language).
- •Having valid proof of identity and age.
Exclusion Criteria
- •Pregnant or nursing mothers 2.Scars, excessive terminal hair or tattoo on the studied area 3.Henna tattoo anywhere on the body (in case of studies involving hair dyes) 4.Dermatological infection or pathology on the level of studied area 5.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye) 6.Any clinically significant systemic or cutaneous disease, which may interfere with study treatment or procedures 7.Chronic illness which may influence the outcome of the study 8.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) 9.Subject in an exclusion period or participating in another food,cosmetic or therapeutic trial.
Outcomes
Primary Outcomes
Change in Skin Irritation Score-erythema & oedema
Time Frame: D2, D4, D6, D9, D11, D13, D16, D18, D20, D23,D24, D25
Secondary Outcomes
- Not Applicable(Not Applicable)
Investigators
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Not Applicable
Skin Sensitization of Baby Forest Ayurveda Tummy Roll OnCTRI/2025/05/086314Baby Forest Ayurveda Pvt Ltd210
Not yet recruiting
Not Applicable
Skin Sensitization Potential of Babyhug Advanced Infused Rosemary OilCTRI/2025/06/089379Brainbees Solutions Limited210
Not yet recruiting
Not Applicable
Sensitization Potential of Snuggle Baby Face Cream and Head to Toe Wash onCTRI/2025/04/086059SNUGGLE CUB (OPC) PVT LTD210
Not yet recruiting
Not Applicable
Sensitization saftey of BTM Ventures Reginald SunscreenCTRI/2025/04/084016Btm Ventures Pvt. Ltd.200
Not yet recruiting
Not Applicable
Skin Sensitization Activity of Marico Purite Baby 3 in 1 (Batch: TF010225)CTRI/2025/03/082331MARICO SOUTH EAST ASIA CORPORATION210