Skin Patch Test to study Human Phototoxicity.
- Registration Number
- CTRI/2018/02/012017
- Lead Sponsor
- Haus Bioceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 39
1.Males or females, 18 to 65 years of age. A representative distribution within this age span is desirable.
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.
1.Have a clinical diagnosis of a dermatological condition other that atopic dermatitis or psoriasis (such as contact dermatitis, cutaneous lymphoma, tineacorporis, 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 taking/using any antihistamines or systemic/topical anti-inflammatory medications (e.g. ibuprofen, corticosteroid, etc.) on a routine or frequent basis. 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.
19.Use or are expecting to use during the study any of (but not limited to) the following: sulfa drugs, tetracyclines, phenothiazines, tranquilizers or antiemetics (e.g. Chlorpromazine, Thorazine, Phenergan), Diurel, Hydroduril, Biabinese or tar containing shampoos ( e.g. Sebritone, Tegrin, etc.) or any other medication bearing a warning to avoid sunlight.
20.Have a history of severe reactions to sun exposure, incuding phototoxicity/photoallergy, solar urticaria, polymorphous light eruption or other photoaggravated disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To confirm that a test substance will not produce evidence of skin phototoxicity following topical contact with the skin by means of a single application patch test.Timepoint: Total 6 Visits for each subject and approximately 2 weeks for each subject
- Secondary Outcome Measures
Name Time Method oneTimepoint: None