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Evaluation of Dermatological safety of Teat Product on Healthy Human Volunteers

Evaluation of Dermatological Safety of Test Product by Primary Irritant Patch Test under 24 hrs occlusion on Healthy Human Volunteers of all skin types. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071386
Enrollment
24
Registered
2024-07-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

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

Conditions

None listed

Interventions

Intervention1: FGL-ZANDU BALM: Dosage: 0.04g, Route of Administration: Skin on back/upper arm, Treatment: Once a day. Intervention2: ZANDU ULTRA POWER BALM: Dosage: 0.04g, Route of Administration: Ski

Sponsors

Emami Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Voluntary men and women ratio of 1:1 between 18 and 65 years. 2. Having healthy skin on test area as assessed by dermatological examination. 3. For whom the investigator considers that the compliance will be correct. 4. Subjects with normal, dry, oily and combination skin in approximately equal ratio. 5. Subjects cooperating is informed of the need and duration of the examination and ready to comply with protocol procedures. 6. Having a signed consent form. 7. Subjects’ willingness to avoid intense UV exposure on test site (sun or artificial UV), during the study. 8. Willingness to avoid excessive water contact or activity which causes excessive sweating during the study. 9. Having valid proof of identity and age. 10. Volunteers evaluated with Fitzpatrick skin type 3 to 5 as per the Fitzpatrick scale.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1. Number of subjects that showed no significant irritation. 2. Score of less than or equal to 2 on the Draize scaleTimepoint: Day 1, Day 2, Day 3 & Day 4

Secondary

MeasureTime frame
Not ApplicableTimepoint: Not Applicable

Countries

India

Contacts

Public ContactMeena Dalal

TrialGuna Private Limited

drsohanshetty@yahoo.co.in08867125414

Outcome results

None listed

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