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N/A N=24 Randomized Single-blind Other

Human Comedogenicity Test

Comedogenicity

Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Microcomedone Score of Follicular Biopsies — 0.84; 0.97 microcomedone score — p=0.274

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Lotion (Device); Negative Control (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Johnson & Johnson Consumer Inc. (J&JCI)
Primary completion
Feb 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Microcomedone Score of Follicular Biopsies
0.84; 0.97 0.274

Summary

Testing comedogenicity potential of a device cream on humans.

Eligibility Criteria

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 i
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03428997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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