Clinical Research Directory

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. Thirty 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.

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.

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.

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.

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.

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.

Menopausal Impact on Skin Aging Among Egyptian Women

The goal of this study is to understand how menopause affects skin aging in Egyptian women between the ages of 40 and 60. The main question the study wants to answer is: Does menopause cause any changes in how the skin ages? To find out, the participants will be divided into two groups based on their menstrual history: * Women who have not yet gone through menopause (premenopausal) * Women who have already gone through menopause (postmenopausal) A researcher will examine the skin of women in both groups to look for signs of aging. Then, the results will be compared to see if there are any differences between the two groups.

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.

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.

A Clinical Study on Pre-operative Intervention With Products During Aesthetic Medicine

This clinical trial aims to evaluate whether a 14-day pre-operative application of the test product (containing MLYAAT-1002®, a proprietary anti-aging complex) can mitigate skin discomfort during Fotona 4D laser therapy (Frac3 and Piano modes) by comparing clinical evaluation, skin attributes measurement and subject self-assessment.

Evaluation of the Skin-Beautifying Effects of Collagen Drinks

This study aims to investigate the skin beauty benefits of collagen drinks in healthy individuals.

Study on Safety and Efficacy of Monopolar Radio Frequency Device for Facial Skin Tightening

Objective: The goal of this clinical trial is to evaluate the safety and efficacy of the VOLNEWMER monopolar radiofrequency device developed by CLASSYS Inc. This study is a prospective, single-center, single-arm, pilot clinical trial. Research Questions: 1. Does the VOLNEWMER device improve skin elasticity? 2. Is the safety profile of the VOLNEWMER device acceptable? Subject Procedures: Subjects will: * Receive a single treatment session using the VOLNEWMER device. * Attend follow-up visits over a 12-week period to assess improvements in elasticity and safety. The primary outcome is the improvement in skin elasticity of the face and cheeks, measured 12 weeks after treatment using the Cutometer R7. Secondary outcomes include the Global Aesthetic Improvement Scale (GAIS). Safety assessments involve monitoring treatment-emergent adverse events (TEAEs) associated with the application of the investigational medical device.

A Clinical Study to Evaluate the Efficacy of Activated Silk™ 27P-α in Subjects, Aged 35-65 Years of Age, to Improve the Signs of Aging

A clinical study with approximately 40 subjects, aged 35-65 years of age, who must have crow's feet and at least one other type of facial fine lines/wrinkles in order to evaluate the efficacy of Activated Silk™ 27P-α to improve the signs of aging.

A Clinical Study to Evaluate the Efficacy of Activated Silk™ 27P-α in Subjects, Aged 35-65 Years of Age, to Improve the Signs of Aging, by Comparing to a Placebo

A clinical study with approximately 15 subjects, aged 35-65 years of age, who must have crow's feet and at least one other type of facial fine lines/wrinkles in order to evaluate the efficacy of Activated Silk™ 27P-α to improve the signs of aging, by comparing to a placebo.

Biometrical Evaluation of the Efficacy of a Food Supplement Versus Placebo

The purpose of this clinical trial is to evaluate whether nutritional supplementation over a 2-month period improves skin physiological parameters. This is a national, single-center, double-blind, randomized pilot study. The study will be conducted using a supplement and a placebo, the safety of which has been assured by the sponsor. Participants will: * Take a food supplement or a placebo once daily for 2 months * Visit the study center at beginning, after 28 days and after 56 days of supplementation. * Keep a diary of their skin status and tolerability The secondary objective is to evaluate product characteristics and performance during normal use in healthy subjects.

Evaluation of the Safety and Efficacy of Profhilo® Structura

Profhilo® Structura is composed of a buffered saline solution of high molecular weight (H-HA) and low molecular weight (L-HA) hyaluronic acid. The high- and low-molecular-weight HA used in the device is obtained by biofermentation and has not undergone chemical modification processes; this results in excellent tolerability of the product. In addition, the HA chains with different molecular weight present in Profhilo® Structura, thanks to a specific and patented treatment of the solution (NAHYCO® Hybrid Technology), interact with each other, giving Profhilo® Structura unique rheological properties that allow higher concentrations of HA to be administered at equal viscosity of the solution. The formulation based on HA with different molecular weight contained in Profhilo® Structura is based on the Hydrolift® Action system, the innovative approach aimed at combating the physiological decrease of HA in the skin, restoring hydration, elasticity and tone, synergistically associating deep hydration with the mechanical lifting action of the skin depression. Thanks to its rheological properties and cohesivity Profhilo® Structura is able to optimally spread and integrate into the interstitial spaces of the adipose tissue. Profhilo® Structura has the specific indication for adipose tissue restoration and is able to counteract facial volume loss.

Efficacy and Safety of Skincare Serum and Cream for Anti-aging of Facial Skin

The primary objective of this study is to assess the efficacy and safety of combination therapy of BABOR® Ultimate ECM Repair Serum and the BABOR® Cure Cream for the improvement of anti-aging through the use of investigator assessments, subject questionnaires/assessments, photography, skin imaging, and reported adverse reactions.