Clinical Research Directory

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.

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 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.

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.

PIEZO-101 First-in-Human Safety and Proof-of-Concept Study

The aim of this first-in-human clinical study is to explore the safety, tolerability, pharmacodynamics, and exploratory efficacy of PIEZO-101, an investigational plasmid DNA biostimulator that aims to restore expression of key proteins in the skin for extracellular matrix rejuvenation. PIEZO-101 is administered using an intradermal injection followed by localized electroporation using the investigational device Piezopen. This clinical trial will study safety and tolerability, pharmacodynamics using biopsies from the left knee, and exploratory efficacy using photography on the décolleté. Up to 8 participants may be enrolled to ensure 6 evaluable participants complete the study.

Effectiveness and Safety of Cellbooster Shape in Healthy Subjects

SUISSELLE has developed a CE marketed (2021) HA-based superficial epidermis/dermis injection filler and skinbooster product, Cellbooster® Shape (CBS). CBS is produced using patented CHAC Technology. It consists of non-crosslinked HA with L-Carnitine and vitamin C. The device is particularly designed for reducing local puffiness by improving microcirculation and hydration. The current post-market clinical investigation is designed to evaluate the efficacy and safety of CBS. For this purpose, healthy subjects with signs of skin aging in the face will receive a 3-session treatment and will be followed-up over 70 days after the initial injection session. Several objective measurements of skin quality will be performed with different instruments allowing to assess skin volume, skin elasticity, skin hydration, and skin microcirculation. Subjective clinical improvement will be evaluated, as well as subject and investigator satisfactions. The safety of the injections will be assessed by collecting the Injection Site Reactions (ISRs) and Adverse Events (AEs).

Study of the Subdermal Implant "Ultracol"

Study of the effectiveness of the medical device "Intradermal implant, sterile ULTRACOL based on polydioxanone (ULTRA V Co., Ltd., Korea) in the correction of skin contour defects.

Skin Hydration and Facial Aging in Women Aged 30-60: An Observational Correlational Study Using Bioimpedance Analysis

This study investigates whether skin hydration levels are related to how old the skin looks. Thirty women aged 30 to 60 years will attend a single visit at a licensed esthetic practice in Florida. Skin moisture will be measured at seven points on the face using the BT-Analyze device. Photographs will be taken and evaluated by a blinded expert cosmetologist using a standard aging scoring system. The study will determine whether women with lower skin hydration tend to show more visible signs of aging.

Evaluation of the Safety and Efficacy of an Injectable Liposomal Gel

The aim of this study is to evaluate the efficacy and safety of intradermal injections of the medical device - hyaluronic acid with the addition of lecithin - in a population of participants with thin, dry, and sagging facial skin.

Preliminary Evaluation of the Safety and Tolerability of SPOT-mRNA01 Subcutaneously Administered in Healthy Subjects

This is a first-in-human, randomized, double-blind, placebo-controlled clinical study to evaluate the Safety and Tolerability of SPOT-mRNA01 injection in healthy adult volunteers.

Focused Ultrasound Treatment for Facial Skin Laxity

The goal of this clinical trial is to learn if focused ultrasound can improve facial skin laxity in adults. The main questions this study aims to answer are: 1. Does focused ultrasound treatment lead to clinically meaningful improvement in facial skin laxity compared with baseline assessments? 2. What treatment-related adverse events occur following focused ultrasound treatment, and how frequently and severely do they occur? Researchers will also compare outcomes between the two sides of the face treated with different focused ultrasound hand-pieces within the same participants to explore potential differences in clinical response and safety using a randomized split-face design. Participants will: Receive a single session of focused ultrasound treatment applied to both sides of the face. Undergo standardized clinical assessments, imaging evaluations, and patient-reported outcome measures at baseline and during follow-up visits. Be monitored for treatment-related adverse events throughout the study period.

Safety and Efficacy of a Microneedling Device Used in Facial Aesthetics

Microneedling (MN), also referred to as collagen induction therapy, uses small needles to create mechanical injury to the skin. The basis of MN relies on physical trauma. It has been proposed that the trauma generated by needle penetration in the skin induces regeneration of the dermis The needles penetrate the stratum corneum and create small holes known as micro-conduits with minimal damage to the epidermis. MN therapy is widely used to improve the appearance of facial scars, stretch marks and rejuvenate photoaged skin. Recently, it has been shown that MN can improve skin wrinkles on the face. MN can be used alone or to increase absorption of topical medications, growth factors, or deliver radiofrequency directly to the dermis. The product tested is a microneedling device with 20 micro-needles of 1.00 mm depth penetration. This microneedling device is considered as a medical device in the US but not in Europe, according to Appendix XVI of the European regulation on medical devices 2017/745 of 5 April 2017. It is not yet commercialized neither in Europe nor in US. This first-in-man, pilot, clinical study is designed to first confirm the cutaneous tolerance of the device and provide some first data on device performance. For this purpose, 33 subjects with mild to moderate wrinkles on the face and seeking improvement of his/her face aspect, will be treated on Day 0 and Day 30 with the microneedling device on the face. Follow-up visits will be done 30 and 60 days after first treatment. Treatment Site Reactions (TSR) and Adverse reactions (ARs) will be collected to evaluate the device safety. Change from baseline of wrinkle severity and Global Aesthetic Improvement Scale (GAIS) will be used to evaluate product performance. Subject evaluation will also be analysed, and photos will be taken to illustrate device effect.

MENA Consensus on Poly-L-Lactic Acid (PLLA) Biostimulator Use in Aesthetic Dermatology

This study aims to develop expert consensus on the safe and effective use of poly-L-lactic acid (PLLA) biostimulators in aesthetic dermatology across the Middle East and North Africa (MENA) region. PLLA is a commonly used injectable treatment that stimulates collagen production, but most guidelines come from Western populations and do not address the unique characteristics of Fitzpatrick III-VI skin types, which are predominant in the MENA region. The study uses a Modified Delphi method, a well-established approach for collecting and refining expert agreement. Dermatologists and aesthetic physicians from MENA countries will participate in two to three online rounds of surveys. In Round 1, experts will answer open-ended questions about indications, contraindications, dilution techniques, safety concerns, anatomical considerations, and training needs related to PLLA. Their responses will be analyzed and converted into structured statements. In Round 2, experts will rate each statement using a 1-to-9 Likert scale, indicating their level of agreement. Items with high agreement will form part of the final consensus. Statements with uncertain or conflicting ratings may undergo a third round for clarification. No patients are involved in the study, and no treatments or interventions will be administered. The study collects professional opinions only, and all responses are anonymized during analysis. The final output will be a region-specific clinical guideline to support safer and more standardized PLLA use across the MENA region. Results will be published in peer-reviewed journals and shared with the aesthetic medical community.

TCRM for Correction of Cheek Including Fine Lines

The purpose of this clinical study is to evaluate benefits and risks of injecting TCRM in the cheek including fine lines. The goal is to show that treatment with TCRM will result in correcting the cheek area including the fine lines at 4 weeks after last treatment (initial injection or touch up) on subjects.