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To study safety of test product in humans.

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/2024/08/072683
Enrollment
26
Registered
2024-08-19
Start date
Unknown
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

None listed

Interventions

Intervention1: 2% Minoxidil + Procapil Solution (Ethanol base): Filter papers dipped in liquid test products (to contain approximately 0.04 ml of test product) will be applied once on upper arm/back o

Sponsors

Cheryl Laboratories Pvt.Ltd
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. Photo 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. Having signed a Consent Form. 7. Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study. 8. Willingness to avoid water contact (i.e.: swimming) or activity which cause sweating (i.e.: exercise, saunaâ?¦), during the course of the study. 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. 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 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 using Draize scale.Timepoint: 48 hours

Secondary

MeasureTime frame
NoneTimepoint: Nil

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