Skin sensitivity test to evaluate the safety of test products.

Not Applicable

Completed

• Registration Number: CTRI/2016/05/006927
• Lead Sponsor: Haus Bioceuticals Inc

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: 116

Inclusion Criteria

In order to be eligible for participation, subjects must be:

1.males or females 18 years of age or older â?? no more than 20% of the panel should be comprised of subjects over the age of 65

2.in general good health as determined by the Medical and Dermatological History Questionnaire (Appendix A) or as having diagnosed with atopic dermatitis or active plaque psoriasis confirmed by a dermatologist

3.able to read, understand and sign an informed consent agreement after being advised of the nature of the study

4.willing to refrain from using lotions, creams, powders or other skin preparations on the skin in the test area for the duration of the study

5.willing to refrain from exposing skin sites to the sun or going to tanning beds for the duration of the study

Exclusion Criteria

Subjects are not eligible for participation if any one of the following applies:

1.have a clinical diagnosis of a dermatological condition other that atopic dermatitis or psoriasis (such as contact dermatitis, cutaneous lymphoma, tinea corporis, etc.), or have nonplaque forms of psoriasis (for example, erythrodermic, guttate, or pustular), or have bacterial infections of the skin, including impetigo or abscesses

2.have a history of skin cancer or have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months

3.have a condition or are taking medication(s) which, in the judgment of the Investigator or Designate, makes the subject ineligible or places the subject at undue risk

4.have pigmentation, extensive scarring, or pigmented lesions in the patch areas, which could interfere with the scoring

5.have had a mastectomy or axillary lymph nodes removed

6.have an autoimmune or immune deficiency disease (e.g. lupus, myositis, Crohns disease, autoimmune thyroid diseases, autoimmune hepatitis, etc.)

7.are currently taking any immunosuppressant medication

8.have insulin-dependent diabetes

9.have asthma or any other chronic respiratory condition requiring daily therapy

10.are currently using on a routine or frequent basis antihistamines or any systemic or topical anti-inflammatory medications (e.g. ibuprofen, corticosteroid, etc.). Maximum acceptable dosage should be determined by written laboratory guidelines.

11.have used a topical anti-inflammatory in the patch area within the last 2 weeks

12.are currently receiving allergy injections, expects to start injections before the conclusion of the study or has had the final injection within a week of the study start

13.are currently participating in another dermal study of any kind

14.are currently participating in any clinical study, which in the judgment of the Investigator or Designate, could potentially affect responses in either study

15.have a confirmed skin allergy as a result of participation in a patch study

16.have a known sensitivity or allergy relating to the substance(s) being evaluated

17.have a known sensitivity or allergy to adhesives, surgical tapes, bandages, etc.

18.have scars, moles, sunburn, tattoos, etc. in the patch area

Study & Design

• Study Type: Interventional
• Study Design: Not specified