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To study safety of test product in Men and Women.

Evaluation of Skin Safety of Test Products (Lotion and Cream) for Primary Skin Irritation Using 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/2025/06/088700
Enrollment
26
Registered
2025-06-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

None listed

Interventions

Intervention1: Venusia Max Lotion: Approximately 0.04 g of test products will be filled in different wells of Patch chambers and will be applied occlusively on upper arm or back of each participant fo

Sponsors

Dr. Reddys Laboratories 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 with 50 percent having sensitive skin as determined by lactic acid sting test. 2. Fitzpatrick Photo type III (Average skin color. Sometimes mild burn, tan about average), IV (Light-brown skin. Rarely burns. Tans easily) and V (Brown skin. Never burns. Tans very easily.) as per Fitzpatrick classification of skin types. 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 or any excipients present in product). 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 scaleTimepoint: 48 hours

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactMs Preetha Paul

Dr Reddys Laboratories Limited

sagarkatare@drreddys.com9223772427

Outcome results

None listed

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