Six Months Evaluation of Next Science Acne Creams on Facial Acne in Adult Females. (NCT03106766) | Clinical Trial Compass
TerminatedEarly Phase 1
Six Months Evaluation of Next Science Acne Creams on Facial Acne in Adult Females.
Stopped: Decision from the Sponsor
United States2 participantsStarted 2017-03-27
Plain-language summary
To assess facial acne vulgaris clinical and psychological outcomes by measuring differences in lesions counts, investigator global assessment, and subjects quality of life scores over 6 months in adult females treated with Next Science™ acne cream 2x or Next Science™ acne cream 1x in a double blind manner.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female ages 18 and above
. Has 20 or more inflammatory lesions on the face (papules and pustules) as determined by qualified examiner at Start of Treatment.
. In the area to be treated, has no significant facial dermatological conditions other than acne (as determined by the investigator) that would interfere with any study treatment or procedure
. Is willing and able to discontinue use of all baseline acne treatments for the duration of their trial participation
. Agrees to refrain from professional facial treatments during their trial participation.
. Agrees to avoid tanning booth use and minimize sun exposure during their trial participation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Is willing and able to follow instructions and procedures including attending scheduled study visits, which will require adequate transportation to the study site
. Is able to read, understand and sign the informed consent document and communicate with study staff and investigator.
Exclusion criteria
. Has more than 2 nodules/cystic acne lesions on the face
. Has a history of significant reactions to topical acne treatments, or a known allergy or hypersensitivity to any listed ingredients
. Has any history of skin malignancy
. Has used any systemic medications (including antibiotics, estrogens, retinoids) primarily for treatment of acne in the 21 days prior to randomization.
. Has used estrogens primarily as treatment for acne in the 21 days prior to randomization (estrogens prescribed for other reasons will be allowed if stable for at least 30 days prior to randomization).
. Has had any professional facial treatments in the 14 days prior to randomization.
. Has received any investigational treatment in the 30 days prior to randomization.
. Have any significant medical problems or other issues that would, in the investigator's judgment, affect their suitability for participation in this trial.