Human Comedogenicity Test

Study Overview
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Brief Summary
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Testing comedogenicity potential of a device cream on humans.

Official Title
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Human Comedogenicity Test

Conditions
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Comedogenicity

Intervention / Treatment
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* Device: Lotion
* Other: Negative Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female. 18 to 45 years old. Individuals that are willing to provide written informed consent and are able to read, speak, write, and understand English. Individuals who are acne-prone with large pores on the back, or individuals who have a history of acne vulgaris on the face or back. Individuals who have had at least a 2-week rest period since participation in any previous clinical studies involving patch applications on the back. Individuals who are willing to avoid direct sun exposure on the back and use of tanning beds for the duration of the study. Generally, in good health based on medical history reported by the subject. Have generally healthy skin condition appropriate for study assessments Available for the entire study duration. Individuals who are willing to keep patch sites as dry as possible and refrain from swimming or soaking in a hot tub for the duration of the study (no showering/bathing restrictions). Willing to cooperate and follow instructions. Female subjects, not of child-bearing potential, must meet at least one of the following criteria: Had a hysterectomy and/or bilateral oophorectomy, Be post-menopausal (amenorrhea for at least 1 year), Had a Tubal Ligation, Surgical sterilization (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy); Female subjects, of child-bearing potential, must agree to practice a medically acceptable form of birth control during the study and 30 days after study completion. Females must have used such birth control for at least 3 months prior to study start; Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include: Established use of hormonal methods of contraception (oral, injected, implanted, patch or vaginal ring). Barrier methods of contraception with or without spermicide: condom or occlusive cap (diaphragm or cervical/vault caps), Intrauterine device (IUD) or intrauterine system (IUS), Surgical sterilization (e.g., in a monogamous relationship with male partner with vasectomy that has been confirmed effective by sperm count check, tubal occlusion, hysterectomy, bilateral salpingectomy). Abstinence from heterosexual intercourse: When this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception; Exclusion Criteria: Individuals with known allergies or sensitivities to common topical skincare products, including adhesives and/or cyanoacrylate (super glue) or ingredients to the test materials for a specific test panel. Deprived from liberty by a judiciary or administrative decision. Having undergone organ excision (kidney, lung, spleen, and liver), an organ transplant, or a skull concussion with extended loss of consciousness within the last 5 years or with present symptoms and/or side effects. Individuals with self-reported UNCONTROLLED metabolic conditions, such as diabetes, hypertension, hyper/hypothyroidism, hypercholesterolemia, etc. Individuals with CONTROLLED health conditions may be excluded from the study at the discretion of the PI or designee: Subjects with conditions that do not affect the skin, such as hypertension and hypercholesterolemia, could be enrolled when their health condition is managed through diet, medication, etc. Subjects with conditions, which might affect the skin, such as hyper/hypothyroidism, diabetes must be excluded, regardless whether their health condition is controlled or not. Subjects who are taking medication for chronic conditions (e.g., insulin, antihistamines, steroidal and non-steroidal anti-inflammatory drugs, antibiotics, etc...) - exception could be made for hypercholesterolemia. Individuals with adult asthma and/or epilepsy. Skin diseases on tested sites (e.g., psoriasis, eczema, erythema, edema, scars, wounds, melanomas, etc.), which may influence the outcome of the study; -----Supplemental Consent During the eligibility screening, individuals who indicate that they have previously had eczema will be advised of the Koebner phenomenon, which refers to the appearance of these conditions either at the patch site or unrelated sites. If the individual chooses to participate in the study, 2 copies of a supplemental consent form will be signed by the subject (1 for the study files and 1 will be given to the subject). Subjects who are self-reported to be pregnant, lactating or planning to become pregnant; females of child-bearing potential who are unwilling or unable to use an acceptable method of contraception during the study. Male subjects who have a pregnant partner. Male subjects whose partner is planning to become pregnant during the study period or is unwilling or unable to use an acceptable method of contraception. Simultaneous participation in any other type of clinical study. An individual who has any condition which in the PI's judgment makes the candidate an inappropriate subject for study participation. Subjects who are related to those persons involved directly or indirectly with the conduct of this study (i.e., PI, sub-investigators, study coordinators, other site personnel, employees of the Sponsor subsidiaries, contractors of the Sponsor, and the families of each). Individuals with a condition or situation which, in the PI's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study. Individual viewed by the PI as not being able to complete the study. Subjects who are planning to use any new personal care products (e.g. makeup) or are planning to change existing brands during the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The experimental lotion and negative control were both applied to test sites on each subjects back.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lotion<br>Test sites were patched with the lotion F #13451-131. | Device: Lotion<br>* Formulated Lotion F# 13451-131 was applied on an occlusive patch and placed on a test site on each subjects back three times a week for four weeks.<br>|
| Other: Negative Control<br>Test sites were patched with undosed occlusive patch. | Other: Negative Control<br>* Control. An undosed occlusive patch was placed on a test site on each subjects back three times a week for four weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microcomedone Score of Follicular Biopsies | Grades for irritations/reactions were The following 5-point global assessment scale was used to grade the follicular biopsies for microcomedones: 0 None (0% No microcomedones) 0.5 Slight (1-24% Smallish horny masses) Mild (25-49% Smallish horny masses) Moderate (50-74% Moderately sized horny masses) Severe (75-100% Larger globoid microcomedones) | 28 days |