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To evaluate safety of a test product for skin irritation

"Skin Irritation Test (Patch Test in Humans) IS 4011:2O18 Guidelines

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/11/038122
Enrollment
24
Registered
2021-11-18
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

None listed

Interventions

Intervention1: Herbal Spray: Single Patch Application 0.04 ml will be applied and will be occluded for 24 hours Control Intervention1: 1% Sodium Lauryl Sulphate (Positive control): Single Patch Applic

Sponsors

Inzpera Healthsciences Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Voluntary men and women between 18 and 65 years having sensitive skin as determined by lactic acid sting test. 2.Photo type III to V. Having apparently healthy skin on test area. 3.For whom the Investigator considers that the compliance will be correct. 4. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 5.Having signed a Consent Form. 6. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study. 7. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna�), during the course of the study. 8 Should be able to read and write (in English, Hindi or local language). 9. Having valid proof of identity and age.

Exclusion criteria

Exclusion criteria: 1. Pregnancy (by history) and lactating women. 2. Scars, excessive terminal hair or tattoo on the studied area. 3. Dermatological infection/pathology on the level of studied area. 4.Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye). 5.Any clinically significant systemic or cutaneous disease, which may interfere with study procedures. 6. Chronic illness which may influence the outcome of the study. 7. Participants on any medical treatment either systemic or topical which may interfere with the performance of the study (presently or in the past 1 month). 8. Participant in an exclusion period or participating in another food, cosmetic or therapeutic trial

Design outcomes

Primary

MeasureTime frame
Evaluation of skin irritation reactions (erythema, oedema, dryness, scaling wrinkling), using Draize scale.Timepoint: 48 hours

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactMs Pooja Yashod

Inzpera Healthsciences Limited

medic@inzpera.com9821467909

Outcome results

None listed

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