Clinical Research Directory

Clinical Research on Deep-Plane Rejuran S Injection for Improvement in the Apperance of Periorbital Hollowing Using a Cannula Technique

The goal of this clinical study is to learn whether DOT PN (Rejuran S), a polynucleotide injectable gel, improves periorbital hollowing (a sunken look around the eyes) in adults aged 25 to 65 years when injected into the deep layer around the eyes with a blunt cannula. Safety will also be assessed. The main question it aims to answer is: \- How much do tear trough depth and brow height change from baseline to Week 16, as measured by 3D imaging? There is no comparison group. All participants receive the study treatment. Participants will: * Receive injections around both eyes (4.0 mL in total per visit) at Weeks 0, 4, 8, and 12 * Have 3D facial photographs taken and report side effects at each visit * Return for follow-up visits at Weeks 16, 20, and 24.

Clinical Evaluation of Dual-Plane Technique PN-Based Treatment for Horizontal Neck Lines Using DNA Fragment Opmizing Technology Polynucleotide (DOT PN)

The goal of this clinical study is to evaluate changes in the appearance of horizontal neck lines after treatment with DOT PN (Rejuran S), a polynucleotide-based injectable medical device, administered using a dual-plane injection technique in adults aged 25 to 65 years with mild to moderate horizontal neck lines. The main question it aims to answer is: \- What is the mean change in horizontal neck wrinkle depth from the start of the study (Week 0) to Week 16, as measured by 3D imaging? All participants will receive the same study treatment; there is no comparison group. Participants will: * Receive DOT PN injections in the neck (4.0 mL per session) every 4 weeks, for a total of 4 sessions (Weeks 0, 4, 8, and 12) * Attend 7 study visits over 24 weeks for 3D imaging, wrinkle grading, questionnaires, and safety checks The injection technique, including the use of a blunt-tip cannula for the deeper layer, is a study-specific procedure defined by the study protocol and standardized across all study sites.

Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation

This pilot study compares fractional CO2 laser resurfacing alone with the same laser combined, in the same session, with micro-focused ultrasound (Ultraformer MPT) for signs of facial skin aging in women aged 50 to 65. Both devices are licensed by Health Canada and are used within their licensed indications. Each participant's two facial sides are compared: one side, chosen at random, receives the combination and the other side receives the laser alone. The second side receives the ultrasound at Month 3, so both sides end with the combination. Ten participants are enrolled at one clinic in Montreal and followed for 6 months. As a pilot, the study estimates the size and variability of the difference between sides to inform a larger trial.

Single-Session Microfocused Ultrasound, AbobotulinumtoxinA and Temporal Hyaluronic Acid Filler for Non-Surgical Brow Lifting

This observational study describes the results of a routine aesthetic treatment for mild to moderate eyebrow drooping (brow ptosis). Thirty-six adults who came to Klinika Estelab (Moscow) asking for rejuvenation of the upper face received, as part of their usual care, one combined treatment session: microfocused ultrasound with visualization (Ultherapy), abobotulinumtoxinA (Dysport) injections, and hyaluronic acid filler in the temples, with a routine toxin touch-up after 2 weeks. The investigators did not assign any treatment; they only added standardized assessments. Eyebrow height was measured on standardized photographs before treatment, immediately after treatment, and at 1, 3, 6, and 12 months. Aesthetic improvement, patient satisfaction, procedural pain, and side effects were also recorded.

Evaluation of MD60002 Device for Facial Skin Aging

This single-center, non-controlled, single-arm clinical study is designed to evaluate the performance and safety of the Class III investigational device MD60002 (composed of highly purified polynucleotides at 3%) for aesthetic use in the treatment of skin imperfections and wrinkles caused by physiological facial aging. A total of 43 adult subjects presenting with facial wrinkles (Lemperle Wrinkle Severity Scale score ≥ 1) will be enrolled. Participants will receive intradermal injections of MD60002 according to a standardized protocol. The primary endpoint is the evaluation of aesthetic improvement measured by the change in the Lemperle Wrinkle Severity Scale (LWSS) score from baseline to the 30-day follow-up visit. Secondary endpoints include patient-reported subjective satisfaction evaluated via the Global Aesthetic Improvement Scale (GAIS), alongside comprehensive safety, tolerability, and device deficiency monitoring in accordance with ISO 14155 guidelines.

AI-Personalized Skincare Regimen for Facial Photoaging in Women

The goal of this clinical study was to learn whether a skincare regimen personalized by an artificial intelligence (AI) skin-analysis tool improves signs of facial skin aging in women aged 35 to 65 with mild-to-moderate facial photoaging. The main questions it aimed to answer were: Does the personalized regimen improve fine lines, wrinkles, firmness, smoothness, tone and other signs of skin aging after 4 and 12 weeks of use? Is the regimen well tolerated? Participants completed an online skin questionnaire and uploaded a facial selfie, and the AI tool assigned one of three night creams. Each participant then used a personalized kit at home for 12 weeks: a vitamin C serum and SPF 30 sunscreen in the morning; the assigned night cream (0.3% retinol, 0.6% retinol, or bakuchiol, each with a triple-peptide complex), an eye cream, and a dark spot remover in the evening; and a daily oral marine collagen supplement. Participants visited the clinic at baseline, week 4 and week 12 for expert skin grading, skin measurements, photographs and questionnaires.

Evaluation of the Performance and Safety of the MD60000 Device in the Treatment of Skin Imperfections Due to Aging.

Here is the English translation of the summary: The Clinical Investigation Plan with code CIP-01-25 outlines a single-center, uncontrolled, single-arm clinical study sponsored by Promoitalia Group S.p.A. and conducted at the Casa di Cura Santa Maria La Bruna in Torre del Greco under the responsibility of Principal Investigator Giuseppe Ferraro, with Teia Research S.r.l. acting as the CRO. The primary objective of the study is to evaluate the aesthetic performance and safety of the MD60000 medical device, an intradermal, biodegradable, sterile, and isotonic gel based on 3.3% linear hyaluronic acid integrated with PLA, intended for the correction of skin imperfections caused by physiological skin aging, such as facial wrinkles. The investigation is conducted pursuant to Article 61 of the European Medical Device Regulation 2017/745 (MDR) in order to collect clinical data for regulatory conformity assessment, adhering to ISO 14155 standards and the Declaration of Helsinki. The study design involves enrolling forty-three adult patients aged between eighteen and sixty-five years with facial skin defects characterized by a baseline score of one or higher on the Lemperle Wrinkle Severity Scale. Patients with skin diseases, active infections, or recent aesthetic treatments in the same anatomical area are excluded, as well as pregnant or breastfeeding women, individuals with a history of allergic reactions to the components, autoimmune diseases, coagulation disorders, or a predisposition to hypertrophic scars or keloids. Participation for each subject ranges between forty-five and sixty-five days, while the overall estimated duration of the entire clinical investigation is approximately six months. The procedural pathway comprises four main visits. During the first screening and baseline visit, eligibility criteria are verified, informed consent and medical history are collected, and baseline photographic evaluations and wrinkle severity assessments are performed. If conditions permit, the first treatment session can occur on the same day, during which the clinician performs an intradermal injection of MD60000 up to a maximum volume of two milliliters. A similar second treatment session follows after an interval of at least fourteen days. The final phase consists of a follow-up visit thirty days after the second treatment, during which final photographs are taken and data regarding patient satisfaction and safety are collected. Treatment efficacy is measured using primary and secondary metrics. The primary performance endpoint is defined as the improvement in the Lemperle scale score between the initial baseline visit and the final follow-up, considered clinically relevant if a median reduction of one point or greater is achieved, confirmed statistically using the Wilcoxon signed-rank test. The secondary endpoint assesses the patient's subjective satisfaction using the Global Aesthetic Improvement Scale (GAIS) thirty days after the completion of treatment, met if at least seventy percent of participants report an rating of improved, much improved, or excellent. Regarding safety, the study evaluates the frequency, severity, and causal relationship of any adverse events or effects occurring during the investigation. The safety profile is considered acceptable in the absence of device-related serious adverse events or device deficiencies, provided that unexpected, mild, device-related adverse events do not exceed a maximum threshold of ten percent. Statistical analysis involves evaluating the Intention-to-Treat (ITT) population set for safety parameters and the Per-Protocol (PP) set for performance metrics.

CyanthOx™ Capsule Efficacy Study

The goal of this clinical trial is to learn whether daily intake of CyanthOx™80 capsules can improve skin, scalp, hair, and selected blood biomarkers in healthy adults after 12 weeks. Researchers will compare participants who take CyanthOx™80 with participants who take a placebo to evaluate its effectiveness and tolerability. A total of 40 participants will be randomly assigned to the CyanthOx™80 group or placebo group, with 20 participants in each group. Participants will not know which capsule they receive. Participants will: Take one capsule daily for 12 weeks. Attend study visits at baseline and weeks 4, 8, and 12. Undergo non-invasive facial skin assessments at baseline, week 4, and week 12. Undergo scalp and hair assessments at baseline and weeks 4, 8, and 12. Provide a 10 mL blood sample at baseline and week 12 for tests related to antioxidant capacity, inflammation, aging, collagen, and blood lipids. Complete questionnaires about skin condition and product satisfaction. Provide collected shed hair at weeks 4, 8, and 12. Have facial, scalp, and hair photographs taken. Identifiable areas will be masked before disclosure. Before each skin or scalp assessment, participants will cleanse the test area with water and rest at room temperature for 30 minutes.

Randomized Trial of Combination Treatment With Sofwave and Sculptra

Evaluation of treatment on the upper arm with Sculptra and Sofwave on the same day versus Sofwave followed by Sculptra 1 month later.

AnteAGE Exosomes and PEARL Multiplier With Microneedling for Facial Skin Quality

This exploratory clinical study evaluated changes in facial skin quality following a series of mechanical microneedling treatments combined with topical AnteAGE Exosomes and PEARL Multiplier and a standardized AnteAGE homecare regimen. Participants underwent three microneedling treatments at approximately 4-week intervals. Outcomes included instrumental skin measurements, standardized facial imaging, investigator assessments, participant-reported outcomes, and assessment of treatment tolerability.

Anti-Wrinkle Efficacy of a Syringic Acid-Containing Emulsion

This randomized, double-blind, split-face controlled study was conducted to evaluate the anti-wrinkle efficacy and safety of a Syringic acid-containing emulsion in healthy female subjects. The test product was an emulsion containing 2% Synox, a Syringic acid-containing ingredient, while the control product was an emulsion without Synox. Participants applied the test and control products to opposite sides of the face according to random allocation for 12 weeks. Skin wrinkle-related parameters were evaluated at baseline and after 4, 8, and 12 weeks of product use using visual assessment, replica-based instrumental measurement, and subject questionnaires. Skin safety was monitored throughout the study period.

AnteAGE Biosomes With Radiofrequency Microneedling for Facial Skin Rejuvenation

This prospective, randomized controlled study evaluated the efficacy and tolerability of AnteAGE Biosome Solution used in conjunction with facial radiofrequency microneedling. Eligible participants with facial rhytids and/or uneven skin tone and texture were randomized 1:1 to an active treatment group or a control group. All participants underwent facial radiofrequency microneedling. Participants in the active group received AnteAGE Biosome Solution during treatment and an AnteAGE skincare regimen, while control participants received hyaluronic acid as the treatment glide and control skincare products. Clinical outcomes included standardized facial photography, investigator assessments, Global Aesthetic Improvement Scale assessments, participant-reported outcomes, and assessment of adverse reactions and post-procedure healing through Day 60.

A Double-Blind, Randomized, Double-Dummy, Active and Placebo-Controlled Clinical Study to Assess the Effect of an Oral Skin Supplement on Skin Health in Healthy Adults

The aim of this study is to investigate the impact of a two skin from within nutritional supplement(s) compared to placebo on skin aging biomarker changes.

A 56-Day Exploratory Study of NatureU® Mind Care BeautyU Caps on Skin Aging Parameters

This was a 56-day, single-center, open-label, single-arm exploratory study evaluating within-participant changes in skin-aging parameters after daily oral intake of NatureU® Mind Care BeautyU Caps in adult women. Participants took one capsule daily for 56 days. The primary outcome was change from baseline in crow's-feet wrinkle count at Day 56 assessed by PRIMOS CR imaging. The secondary outcome was change from baseline in stratum corneum hydration at Day 56 assessed by Corneometer CM 825. Additional exploratory outcomes included other wrinkle topography parameters, skin elasticity, radiance, pigmentation, pore-related parameters, dermal thickness and density, and participant-reported skin appearance outcomes.

Effect of Topical Sulforaphane on Skin Aging and With Ultraviolet and Visible Light Exposure

The study is to compare the expression of both keratin 16 and 17 before and after application of sulforaphane on both photoprotected and photoexposed area, and to determine whether these findings alter skin aging as well as skin response to ultraviolet (UV) and visible light exposure.

MItochondrial Intervention for Resilience in Older Adults With Coenzyme Q10

This randomized, double-blind, placebo-controlled clinical trial will investigate whether 10 weeks of CoQ10 supplementation can improve biological resilience and functional health in community-dwelling adults aged 65 years or older with signs of reduced biological resilience or prefrailty. Participants will be randomly assigned in a 1:1 ratio to receive either 200 mg of CoQ10 daily or matching placebo for 10 weeks. The study will assess the effects of CoQ10 supplementation on mitochondrial functional resilience, chronic low-grade inflammation, metabolic health, physical performance, cognitive function, and objective measures of skin aging. The study will also investigate whether baseline biological and functional characteristics can identify individuals who are more likely to benefit from CoQ10 supplementation. An exploratory aim is to develop a multidimensional composite index of biological resilience integrating molecular, biochemical, functional, and clinical measures of aging. The study will provide evidence on whether a mitochondria-targeted intervention with CoQ10 may represent a potential strategy for improving functional resilience and reducing features of prefrailty in older adults.

Objective Evaluation of Intradermal MSC-Derived Exosome Therapy on Facial Skin Quality

This study aims to evaluate the potential effects of mesenchymal stem cell-derived suspended exosome therapy on facial skin quality using objective imaging analysis. Forty adult participants will receive intradermal exosome applications in three treatment sessions performed at one-month intervals. Facial skin analysis will be conducted using the VISIA imaging system before each treatment session and six months after the final treatment. The study will examine changes in multiple facial skin characteristics including wrinkles, pigmentation, skin texture, pores, UV spots, red areas, brown spots, and porphyrins to determine whether exosome therapy may improve overall facial skin quality.

NVTIA® Ergothioneine for Healthy Aging and Skin Health

This study is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of NVTIA® Ergothioneine, a branded ergothioneine ingredient, on healthy aging biomarkers and skin health in healthy adults aged 40 to 65 years. Participants will receive either NVTIA® Ergothioneine or a matching placebo once daily for 12 weeks. The primary objective of this study is to evaluate the effects of NVTIA® Ergothioneine supplementation on biomarkers associated with oxidative stress and healthy aging. Secondary objectives include assessment of skin elasticity, skin hydration, inflammatory biomarkers, and overall safety. The findings of this study are expected to provide clinical evidence supporting the role of NVTIA® Ergothioneine in promoting healthy aging and maintaining skin health.

A Pilot Study to Evaluate the Expanded Reach of Decentralized Digital Skin Health Clinical Studies

This is a randomized, decentralized, non-interventional clinical study. The primary objective of this study is to develop execution and efficiency metrics from completion of this study to inform on the potential design for future projects. The secondary objective of this study is to assess the main study endpoints across balanced attributes of study sub-populations.

A Clinical Trial to Evaluate the Effects of Naila's Collagen Marine Plus Food Supplement on Skin Hydration, Elasticity, Fine Lines and Wrinkles, and Hair and Nail Health

This is a single-group, open-label, virtual (decentralized) clinical trial evaluating the effects of Naila's Collagen Marine Plus Food Supplement on skin hydration, elasticity, firmness, fine lines and wrinkles, and hair and nail health over 12 weeks. Forty healthy adults aged 40-60 years with self-reported mature skin showing early signs of aging will take one sachet of the supplement daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12. Participants will also submit standardized facial and hair photographs at Baseline and Week 12 for evaluation by a board-certified dermatologist. The primary objectives are to assess changes in skin aging parameters and hair health. Secondary objectives include evaluation of nail health, hair shedding and density, participant-reported satisfaction, and product safety and tolerability.

Hyaluronic Acid Crosslinking Clinical Study

This prospective observational case series aims to evaluate the clinical efficacy, safety, and patient satisfaction associated with hyaluronic acid dermal fillers with different degrees of divinyl sulfone (DVS) crosslinking. Twenty adult participants undergoing facial aesthetic treatment will be followed for 90 days. Clinical outcomes will be assessed using three-dimensional imaging (Vectra® 3D), soft tissue ultrasonography, the Global Aesthetic Improvement Scale (GAIS), Net Promoter Score (NPS), Likert satisfaction scales, and standardized adverse event monitoring.

TCA Peel and Photobiomodulation for Hand Rejuvenation

Photodamage is a growing concern in contemporary society because promotes early skin aging and different pathologies resulting from prolonged and repeated exposure to ultraviolet solar radiation, which is considered the main extrinsic factor of this process. Affected by radiation, the hands play an important role in the manifestation and visibility of aging, as they are very exposed body regions. The study proposal is developed by the potential mechanism of tissue repair, skin rejuvenation, anti-inflammatory and analgesic effects of photobiomodulation, complementing the benefits of chemical peel. The main objective of this randomized, controlled, double-blind clinical trial is to compare the photorejuvenating effects of 20% trichloroacetic acid (TCM) peel applied alone and the effects of the association of 20% TCM peel with 660nm light emitting diode (LED) photobiomodulation (PBM) in the treatment of the back of the hands. Participants will be divided into 2 groups and will receive different therapies according to the allocation group. Group A will be subjected to 04 chemical peel sessions of 20% TCM and PBM. Group B will also receive the 04 chemical peel sessions of 20% TCM with PBM simulation. The application sessions will be monthly and the consultations for fortnightly evaluations. Analysis of photoaging characteristics such as fine and coarse wrinkles, dyschromias and global assessment of the back of the hands will be carried out using periodic standardized photographs. A visual-analog pain scale and a 5-point Likert scale will also be applied regularly to assess participants' satisfaction.

Homocysteic Acid Biostimulator for Photoaged Facial Skin

This study evaluated whether a chemical skin biostimulator containing ammonium trichloroacetate, homocysteic acid, phytic acid and citric acid can improve signs of photoaged skin in women with mature skin. Twenty-five women received four treatment sessions two weeks apart, followed by a home-care skincare regimen. Skin firmness, wrinkles, skin texture, hydration, sebum production and, in participants with hyperpigmentation, skin tone uniformity were measured before treatment and at 2 and 12 weeks after the treatment series to determine whether the biostimulator produces lasting improvement in photoaged skin without the downtime associated with traditional chemical peels.

Poly-L-lactic Acid (PLLA) Injection for Neck Skin Laxity: A Pilot Study

Skin aging of the neck commonly leads to wrinkles and skin laxity due to the gradual loss of collagen and structural support in the skin. Although several treatments are available, effective non-surgical options for improving neck skin laxity remain limited. This pilot study aims to evaluate the effectiveness and safety of Poly-L-Lactic acid (PLLA) injections for improving neck skin laxity.