A Study to Determine the Safety and Sensitizing Potential of HAT1 Topical Products Using Skin Sensitivity Patch Tests

• Status: Completed
• Trial end date: 2016-07-21
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this clinical study is to assess the irritation and sensitisation potential of HAT1 topical products after repeated patch applications to healthy human participants by following conventional Repeated Insult (HRIPT), Cumulative Irritation (CIT), and Phototoxicity (PT) methodologies under the supervision of dermatologists.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Haus Bioceuticals

Criteria

The study population in this report comprises of healthy normal subjects, patients with active plaque psoriasis, and patients with atopic dermatitis.

Inclusion Criteria:

• Males or females 18 years of age or older - no more than 20% of the panel should be comprised of subjects over the age of 65.

• In general good health as determined by the Medical and Dermatological History Questionnaire, or as having diagnosed with atopic dermatitis confirmed by the investigating dermatologist, or as having diagnosed with active plaque psoriasis confirmed by the investigating dermatologist.

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

• 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.

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

Exclusion Criteria:

• Have a clinical diagnosis of a dermatological condition other that atopic dermatitis or psoriasis (such as contact dermatitis, cutaneous lymphoma, tinea corpori's, etc.), or have non plaque forms of psoriasis (for example, erythrodermic, guttate, or pustular), or have bacterial infections of the skin, including impetigo or abscesses.

• 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.

• 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.

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

• Have had a mastectomy or axillary lymph nodes removed.

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

• Are currently taking any immunosuppressant medication 8. Have insulin-dependent diabetes.

• Have asthma or any other chronic respiratory condition requiring daily therapy

• 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.

• Have used a topical anti-inflammatory in the patch area within the last 2 weeks

• 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

• Are currently participating in another dermal study of any kind

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

• Have a confirmed skin allergy as a result of participation in a patch study.

• Have a known sensitivity or allergy relating to the substance(s) being evaluated.

• Have a known sensitivity or allergy to adhesives, surgical tapes, bandages, etc.

• Have scars, moles, sunburn, tattoos, etc. in the patch area.