Human Comedogenicity Test
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ClinicalTrials.gov Identifier: NCT03428997 |
Recruitment Status :
Completed
First Posted : February 12, 2018
Results First Posted : August 2, 2019
Last Update Posted : July 3, 2023
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Tracking Information | |||||||||
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First Submitted Date ICMJE | January 19, 2018 | ||||||||
First Posted Date ICMJE | February 12, 2018 | ||||||||
Results First Submitted Date ICMJE | January 25, 2019 | ||||||||
Results First Posted Date ICMJE | August 2, 2019 | ||||||||
Last Update Posted Date | July 3, 2023 | ||||||||
Actual Study Start Date ICMJE | November 20, 2017 | ||||||||
Actual Primary Completion Date | February 5, 2018 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Microcomedone Score of Follicular Biopsies [ Time Frame: 28 days ] 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)
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Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Human Comedogenicity Test | ||||||||
Official Title ICMJE | Human Comedogenicity Test | ||||||||
Brief Summary | Testing comedogenicity potential of a device cream on humans. | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: The experimental lotion and negative control were both applied to test sites on each subjects back. Masking: Single (Investigator)Masking Description: The evaluator was blind to the placement of the interventions on the test sites. Primary Purpose: Other
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Condition ICMJE | Comedogenicity | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Completed | ||||||||
Actual Enrollment ICMJE |
24 | ||||||||
Original Enrollment ICMJE | Not Provided | ||||||||
Actual Study Completion Date ICMJE | February 5, 2018 | ||||||||
Actual Primary Completion Date | February 5, 2018 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion 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);
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:
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.
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 45 Years (Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03428997 | ||||||||
Other Study ID Numbers ICMJE | CO-171106085430-SACT | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | Johnson & Johnson Consumer and Personal Products Worldwide ( Johnson & Johnson Consumer Inc. (J&JCI) ) | ||||||||
Original Responsible Party | [Redacted] | ||||||||
Current Study Sponsor ICMJE | Johnson & Johnson Consumer Inc. (J&JCI) | ||||||||
Original Study Sponsor ICMJE | [Redacted] | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Johnson & Johnson Consumer and Personal Products Worldwide | ||||||||
Verification Date | June 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |