Dermal sensitization study of colorant formulations containing naturally derived colorants

Not Applicable

Completed

• Registration Number: CTRI/2012/12/003172
• Lead Sponsor: Plant Lipids P Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

•Males or females, age 21 to 65 years of age and in good general health

•Individuals of any skin type or race provided their degree of skin pigmentation does not significantly interfere with evaluations

•Individuals free of any systemic or dermatological disorder including known allergies to skin care products or topical drugs, or, other medical conditions which, in the opinion of the investigator, might interfere with the conduct of the study, interpretations of the results, or increase the risk of adverse reactions

•Individuals able to understand, and provide written informed consent.

•Individuals who are believed to be dependable, who agree to complete the course of the study, and comply with instructions.

Exclusion Criteria

•Women who are self-reported pregnant, nursing or planning a pregnancy

•Individuals with a history of any dermatological disease or condition, including but not limited to active atopic dermatitis, psoriasis, eczema, active seasonal allergies or skin cancer within the past 6 months

•Individuals with abnormal skin pigmentation at the test sites which might interfere with subsequent evaluations of dermal responsiveness

•Individuals taking medications which might interfere with the test results, including any regimen of corticosteroids (equivalent to > 10 mg prednisone), steroidal/non-steroidal anti-inflammatory drugs, antihistamines or immunosuppressive drugs

•Individuals who have applied any type of topical anti-inflammatory medication to the test sites within two weeks prior to enrollment

•Individuals with any other skin condition that would interfere with the conduct of the study

• Individuals who have undergone a bilateral mastectomy with lymph node removal, a unilateral mastectomy with lymph node removal within the last year, or a bilateral axillary lymph node removal

•Individuals with a history of immune deficiency or auto-immune disease

•Individuals who are currently receiving allergy injections, have received allergy injections within one week prior to enrollment, or expect to begin receiving allergy injections during the study

•Individuals treated for malignancy within 6 months prior to enrollment

•Individuals who are currently under treatment for asthma or diabetes

•Current enrollment in any other research study or participation in a patch test study within 30 days prior to the start of this study

•Individuals who are known tape/adhesive reactors

•Treatment with ultraviolet (UV) light (including tanning) during the previous 3 weeks.

•Any psychiatric illness that prevents the subject from completing the study or interfere with the interpretation of the study results.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of subjects with dermal sensitivityTimepoint: Day 0, 2, 4 and 7

Secondary Outcome Measures

Name	Time	Method
Assess the dermal sensitivity using HRIPT ScaleTimepoint: Day 0, 2, 4 and 7