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Dermatological safety study on healthy Human Subjects.

Assessment of the skin Irritancy of Different Formulations in Human using patch test on Sensitive Skin

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/01/017039
Enrollment
24
Registered
2019-01-10
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

None listed

Interventions

Intervention1: 1. Odomos Mosquito repellent Patches. 2. Odomos Fabric Roll-On: Products were evaluated through single application closed patch test under occlusion for 24 hrs post patch removal. Afte

Sponsors

Dabur India Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Voluntary men and /or women. 2. Photo Type III and IV. 3. Having Apparently healthy skin on test area (upper arms) 4. Willingness to discontinue the use of cleansing and/or cosmetic products in the treatment areas during the course of the study 5. For whom the investigator considers that the compliance will be correct. 6. Cooperating, informed of the need and duration of the examinations [3 visits (more if necessary)] and ready to comply with protocol procedures. 7. Having signed a Consent Form and will be once informed orally and in writing of all information concerning the study procedures and study objectives. 8.Willingness to avoid intense UV exposure on test site (sun or artificial UV), during the course of the study. 9. Willingness to avoid water contact (i.e.: swimming) or activity which causes excessive sweating (i.e.: exercise, saunaâ?¦), during the course of the study. 10. Ready to wear loose cotton clothes. 11. Should be able to read and write (in English, Hindi or Marathi). 12. Having valid proof of identity and age proof. 13. For Women only - A women who is NOT pregnant or NOT a nursing (Lactating) mother

Exclusion criteria

Exclusion criteria: 1. People who have a job involving water contact or a job which causes perspiration. (Routine work can be done. No carrying out strenuous activities like excessive/brisk walking, exercising etc). 2. Scars, excessive terminal hair or tattoo on the studied area or henna tattoo anywhere on the body. 3. Dermatological infection/ pathology on the level of studied area. 4. Hypersensitivity, allergy antecedent (to any cosmetic product, raw material or hair dye). 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. 9. For Women only, A women who is pregnant or is a nursing (Lactating) mother 10. For Women only, Positive results in UPT test

Design outcomes

Primary

MeasureTime frame
To assess the skin irritation potential of different formulations manufactured by Dabur India Ltd by 48 hours patch test under complete occlusion on healthy human subjects.Timepoint: 0hr, 24hr, 48hrs

Secondary

MeasureTime frame
Overall safety of SubjectsTimepoint: 0hr, 24hr, 48hrs

Countries

India

Contacts

Public ContactDr S V Devasthale

DABUR INDIA LTD

ravi.tripathi@dabur.com01203378659

Outcome results

None listed

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