Efficacy in Daily Use of a Novel Skin Care Product for the Treatment of Photoaged Skin (NCT03144193) | Clinical Trial Compass
UnknownNot Applicable
Efficacy in Daily Use of a Novel Skin Care Product for the Treatment of Photoaged Skin
United Kingdom60 participantsStarted 2017-06-01
Plain-language summary
Photoaged or chronically sun-exposed skin is characterised by a number of clinical features including fine and coarse wrinkles. The pathogenesis of wrinkle formation has yet to be determined fully but recent work suggests that ultraviolet radiation-induced reduction in dermal fibrillin (in the form of fibrillin-rich microfibrils) is important. Using an extended in vivo patch test assay, it has been identified that skin care products - currently marketed by CG Skin Ltd - increase the deposition of these microfibrils in photoaged dermis and hence have the potential to repair photoaged skin. The Investigators now propose to examine the efficacy of the product in randomized, placebo-controlled clinical trial.
Who can participate
Age range
40 Years
Sex
ALL
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:
* Have moderate to severe photoaging of facial skin (grade 6 or above on the Griffiths scale);
* Willing to submit to examination of facial skin, hands and forearms;
* Willing to submit to self-treatment with product or placebo cream on face, hands and forearms, including wrists and extensor forearms, for 6 months;
* Willing to submit to clinical photography;
* Willing to submit to 3 mm punch biopsies from the wrist at beginning and end of trial;
* Signed informed consent.
Exclusion Criteria:
* Skin disease that would impair evaluation of the test sites;
* Topical or systemic retinoid within the past 6 months and 12 months respectively prior to entry to the study;
* Topical steroid or other topical drugs at treatment sites for at least two weeks prior to study entry;
* History of use of experimental drug or experimental device in the 30 days prior to entry into the study;
* Any significant cosmetic treatment for skin rejuvenation i.e. dermabrasion, chemical peels, face-lifts;
* Known allergy to any of the product or placebo ingredients;
* History of keloid scars.
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.
1This trial is studying a novel skincare product for photoaged skin — do you know anything about what's actually in this product, and whether its ingredients have any known risks or interactions with treatments I'm already using?
2Since this trial has an 'unknown' recruitment status, is it still actively enrolling patients, and if not, are there similar studies I could look into instead?
3The main thing being measured here is wrinkle appearance using a photonumeric scale — does that kind of cosmetic outcome align with what I'm most hoping to address, or should I be looking at treatments with more clinical endpoints?
4Because this is listed as Phase NA — meaning it may not follow the standard drug-trial phase structure — what does that tell us about how much is already known about this product's safety and how well it works?
5Are there established dermatology treatments for photoaged skin that you'd recommend I consider first, before looking at a trial like this one?
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.
What they're measuring
1
Change in clinical appearance using a validated photonumeric wrinkle scale