Extension Phase 3 Open label clinical study designed to evaluate the dermatological safety on healthy human subjects.

Extension Evaluation of dermatological safety of Investigational Products by Repeat insult patch test – under complete occlusion on healthy human subjects. - CROM12/2020

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027388

Enrollment

Registered

2020-08-26

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

None listed

Interventions

Intervention1: Dermal Repeat insult Patch test: Dermal Cosmetics Repeat insult patch test application of 5 products on skin. Duration- period of 38 days for each subject. Control Intervention1: NA: Si

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects in age group 18 to 65 years (both the ages inclusive) 2. Healthy male/female subjects. 3. Subjects with Fitzpatrick skin type III to V. 4. Subjects willing to give a written informed consent. 5. Subjects willing to maintain the patch test in position for 24 hours. 6. Subject having not participated in a similar investigation in the past one month. 7. Subjects willing to come for regular follow up visits. 8. Subjects ready to follow instructions during the study period.

Exclusion criteria

Exclusion criteria: 1. Infection, allergy on the tested area. 2. Skin allergy, antecedents or atopic subjects. 3. Athletes and subjects with history of excessive sweating. 4. Cutaneous disease which may influence the study result. 5. Subjects on oral corticosteroid. 6. Subjects participating in any other cosmetic or therapeutic study. 7. Any history of underlying uncontrolled medical illness including diabetes, liver disease or history of alcoholism, HIV or any other serious medical illness.

Design outcomes

Primary

Measure	Time frame
Safety on dermal Repeat insult patch tests for all the products as per RIPT protocol – 3 weeks expsore followed by gap of 2 weeks and then reapplication and observation for 3 days after 24 hrs.Timepoint: 38 days	—

Secondary

Measure	Time frame
Safety on dermal Repeat insult patch tests for all the products as per RIPT protocol – 3 weeks expsore followed by gap of 2 weeks and then reapplication and observation for 3 days after 24 hrs.Timepoint: 38 days	—

Countries

India

Contacts

Public ContactDr Vijaykumar Shivajirao Patil

CROM Clinical Research and Medical Tourism Pvt. Ltd.

laddhl@gmail.com9158592177

Outcome results