FindTrial
Sign In

Evaluation of the Skin Irritation and Skin Sensitization Potential by Human Repeat Insult Patch Test (HRIPT).

Evaluation of the Skin Irritation and Skin Sensitization Potential of Test Products in Healthy Adult Human Subjects by Human Repeat Insult Patch Test (HRIPT). - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/02/063099
Enrollment
240
Registered
2024-02-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: HBWW-052005: Neat, 0.04mg, single dose, topical application, 24 hr Intervention2: HBBW-122006: Neat, 0.04mg, single dose, topical application, 24 hr Intervention3: HBBL-122003: Neat, 0.

Sponsors

Himalaya Wellness Company
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 18-65 years (both inclusive) at the time of consent. 2. Sex: Males and non-pregnant/non-lactating females. 3. Subjects having Phototype III to V 4. Subjects having apparently healthy skin on test area 5. Subjects for whom the investigator considers that the compliance will be correct.

Exclusion criteria

Exclusion criteria: 1. Subject who is pregnant or lactating. 2. Subjects 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) that can interfere with the reading. 3. Subjects with dermatological infection/pathology on the level of studied area. 4. Subjects with hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye). 5. Subjects with any clinically significant systemic or cutaneous disease, which may interfere with study procedures.

Design outcomes

Primary

MeasureTime frame
To evaluate the test products for their skin irritation and skin sensitization potential by repetitive applications on the skin of human subjects.Timepoint: Diagnostic Patch Time points: 0hour and 48 hours. Induction Phase: 0 hr, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384, 408, 432 hours. Resting Period of 14 days. Challenge phase: 24 hours, 48 hours and 72 hours.—

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable—

Countries

India

Contacts

Public ContactDr Simran Sethi

Cliantha Research

pjoshi@cliantha.com8000085049

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026