ComedogenicityNCT03428997
Human Comedogenicity Test
A study testing Lotion in people with Comedogenicity, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
Trial summary
Testing comedogenicity potential of a device cream on humans. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Comedogenicity
- What is being tested?
- Lotion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2017to 5 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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;
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Testing comedogenicity potential of a device cream on humans.
- Conditions
- Comedogenicity
- Being tested
- Lotion, Negative Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LotionDevice
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.
Negative ControlOther
Control. An undosed occlusive patch was placed on a test site on each subjects back three times a week for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lotion | Experimental | Test sites were patched with the lotion F #13451-131. Receives: Device: Lotion |
| Negative Control | Other | Test sites were patched with undosed occlusive patch. Receives: Other: Negative Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start20 Nov 2017
- Primary completion5 Feb 2018
- Study completion5 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ComedogenicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The experimental lotion and negative control were both applied to test sites on each subjects back.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428997
- Sponsor's protocol ID
- CO-171106085430-SACT
- Status last verified
- Jun 2023
- First submitted
- 19 Jan 2018
- Last updated
- 3 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Comedogenicity Test
- ClinicalTrials.gov ID
- NCT03428997
- Acronym / sponsor ID
- CO-171106085430-SACT
- Conditions
- Comedogenicity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)Industry (pharma, biotech, devices)
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 5 Feb 2018 (actual)
- Study completion
- 5 Feb 2018 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Posted 2 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Testing comedogenicity potential of a device cream on humans.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The experimental lotion and negative control were both applied to test sites on each subjects back.
| Arm | Type | Receives |
|---|---|---|
| Lotion | Experimental | Device: LotionTest sites were patched with the lotion F #13451-131. |
| Negative Control | Other | Other: Negative ControlTest sites were patched with undosed occlusive patch. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (20 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LotionFormulated 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. | Device | Lotion |
| Negative ControlControl. An undosed occlusive patch was placed on a test site on each subjects back three times a week for four weeks. | Other | Negative Control |
Primary outcome
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) 1. Mild (25-49% Smallish horny masses) 2. Moderate (50-74% Moderately sized horny masses) 3. Severe (75-100% Larger globoid microcomedones)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Comedogenicity
Recruiting
Dermal and Ophthalmological Acceptability and Comedogenicity Assessment of a Cosmetic Product
Oily Skin, Acne Prone Skin
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lotion in people with Comedogenicity, run by Johnson & Johnson Consumer Inc. (J&JCI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microcomedone Score of Follicular Biopsies (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.