Skin Irritation potential of Topical Formulations by Human patch test

Phase 1

Completed

• Registration Number: CTRI/2018/03/012451
• Lead Sponsor: Dabur India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2006-10-31
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified