Human Phototoxicity Skin Patch Test to evaluate the dermatological safety of test products of Haus Bioceuticals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
Study Objective:
The purpose of this study is toconfirm that a test substance will not produce evidence of skin phototoxicityfollowing topical contact with the skin by means of a single application patchtest.
Study Duration: Approximately 2 weeks for each subject.
Study Population: Total 41 subjects ( 25 normal healthy subjects, 06 subjects with atopic dermatitis and 10 subjects with active plaque psoriasis).
Methodology:
Each test substance will be applied to 2identical contralateral patches. Thesepatches will be applied to selected sites on the lower or middle back of eachtest subject. Reinforcing tape (e.g.Scanpore®, Micropore®, etc.) can be used to secure thepatch, as necessary. For each testsubstance, one site will be irradiated and one site will be anon-irradiated control site. Thesubjects will leave the patches in place and dry for 24 hours (±1 hour). These applications will be documented on theTopical Treatment, Irradiation and Scoring form After 24 hours (±1 hour), the patches will beremoved and discarded by test facility personnel. Skin sites will be wiped with a dry gauze toremove any excess test substance.
Aftercompletion of 24 hours of occlusion, both patch systems will be taken off. 30minutes post removal of the patch dermatological assessment of the sites(including controls) will be done following which one of the two sites and untreatedirradiated control site (randomized and investigator blinded) will beirradiated with 0.5 MED.
10 minutespost irradiation another reading will be taken by thedermatologist/investigator.Subsequent readings will be taken at 24 and 48 hours post irradiation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.).
- •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.
- •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.
- •15.Have a confirmed skin allergy as a result of participation in a patch study.
- •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.
结局指标
主要结局
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.
时间窗: Total 6 Visits for each subject and approximately 2 weeks for each subject
次要结局
未报告次要终点