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Skin Irritation potential of Topical Formulations by Human patch test

Patch Test (Skin Irritation)

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/03/012451
Enrollment
10
Registered
2018-03-09
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: Odomos Mosquito Repellent Cream: 8 mg/sqcm of Odomos Mosquito repellent Cream formulation was taken on a filter paper disc and introduced into the finn chamber. The finn chamber was pat

Sponsors

Dabur India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the written informed consent. 2. Normal findings in the physical and clinical examinations. 3. Clinical Laboratory values within 10% above or below the laboratoryâ??s stated normal range, unless the investigators along with physicians decide that they are not clinically significant and record this fact on the case report form. 4. A Non-Smoker. 5. Asian males of Indian origin.

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity to the study formulations or related products. 2. Significant history or presence of psychiatric, gastro intestinal, liver or kidney disorder/impairments, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of common medications. 3. Significant history of asthma, chronic bronchitis or other bronchospastic condition. 4. Significant history or presence of glaucoma, cardiovascular or hematological disease. 5. Any clinically significant illness during the 4 weeks prior to day one of this study. 6. Maintenance therapy with any drug, or history of drug dependency, alcohol abuse, or serious neurological or psychological disease. 7. Participation in a clinical trial with an investigation drug within 90days preceding day 1 of the current study. 8. Use of enzyme-modifying drugs within 30 days prior to day 1 of this study. 9. Use of any systemic medication (including OTC preparations) within 14 days proceeding day 1 of this study. 10. HIV and Hepatitis and Australian Antigen positive volunteers.

Design outcomes

Primary

MeasureTime frame
No serious adverse events weer recorded for any volunteer during the study. all test samples have classified as NON-IRRITANT as per the Draize Scores Obtained.Timepoint: 4 hrs, 24hrs

Secondary

MeasureTime frame
NilTimepoint: Nil

Countries

India

Contacts

Public ContactDr S V Devasthale

Dabur India Limited

ravi.tripathi@dabur.com01203378659

Outcome results

None listed

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