Skip to content

To evaluate safety of test product in men and women.

Skin Irritation Test (Patch Test in Humans)IS 4011:2018 Guidelines. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093842
Enrollment
26
Registered
2025-08-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

None listed

Interventions

Intervention1: Health E wipes: Wipes will be cut into pieces of 1.5 X 1.5 cm2 and filled in wells of patch chambers and will be applied occlusively on upper arm/back of each participant. Patches will

Sponsors

Mor Medics Science & Technologies
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Voluntary men and women (preferably equal number of males and females) between 18 and 65 years. 2. Fitzpatrick skin type III to V. 3. Having apparently healthy skin on test area. 4. For whom the Investigator considers that the compliance will be correct. 5. Cooperating, informed of the need and duration of the examinations, and ready to comply with protocol procedures. 6. Willing to give written informed consent to participate in the trial after informing all information concerning the trial procedures and trial objectives. 7. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the trial. 8. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, sauna?), during the course of the trial. 9. Should be able to read and write (in English, Hindi, or local language). 10. Having valid proof of identity and age.

Exclusion criteria

Exclusion criteria: 1. Pregnancy (by history) and lactating women. 2. Athletes and participants with history of sweating. 3. Scars, excessive terminal hair, or tattoo on the studied area. 4. A participant who the Investigator feels will not be compliant with trial requirements 5. Dermatological infection/pathology on the level of studied area. 6. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material, hair dye). 7. Any clinically significant systemic or cutaneous disease, which may interfere with trial procedures. 8. Chronic illness which may influence the outcome of the trial. 9. Participants on any medical treatment either systemic or topical which may interfere with the performance of the trial (presently or in the past 1 month). 10. 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: None

Countries

India

Contacts

Public ContactMs Preetha Paul

Clinical Aesthetics and Investigative Management Service Pvt. Ltd. (C.L.A.I.M.S.PVT.LTD.

preetha@claimsclinical.com66758851

Outcome results

None listed

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