To test the safety of test product by primary irritation patch test on Sensitive Skin

Evaluation of Skin Safety of test product using 24 Hours Patch Test Under Complete Occlusion on Adult Healthy Human Participants with Non-Sensitive Skin

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/053321

Enrollment

Registered

2023-05-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

None listed

Interventions

Intervention1: Gulabari Rose water with Aloe vera: Gulabari Rose water with Aloe vera Route of Administration: Skin on back/ upper arm Dosage: Quantity Sufficient Treatment Period: 9 days for each sub

Eligibility

Inclusion criteria

Inclusion criteria: 1.Voluntary men and women ratio of 1:1 between 18 and 65 year 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 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 (for example swimming) or activity which causes excessive sweating (that is exercise, sauna ….), 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 (Appendix IV).

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 (presently or in the past 1 month). 8.Subject in an exclusion period or participating in another food, cosmetic, or therapeutic trial.

Design outcomes

Primary

Measure	Time frame
• Number of subjects that showed No significant irritation. • Score of less than or equal to 2 on the Draize scale.Timepoint: Day 1, Day 2, Day 3, Day 8	—

Secondary

Measure	Time frame
Not ApplicableTimepoint: Not Applicable	—

Countries

India

Contacts

Public ContactMeena Dalal

Dabur India Limited

sasibhushan.vedula@dabur.com

Outcome results