Skin Aging Clinical Trials

Open Label Study to Assess Long-term Safety of Repeat Administration of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
This study will evaluate the long-term safety of botulinum toxin type A for the treatment of moderate to severe crow's feet lines after repeat application.
Status: Recruiting Start Date: February 2013 Completion Date: December 2015
Comparison of Escalating Doses of IncobotulinumtoxinA (Xeomin®) in the Treatment of Glabellar Rhytids
The objective of the study is to compare the efficacy and duration of escalating doses of IncobotulinumtoxinA (Xeomin®) in the treatment of glabellar rhytids (frown lines between the eyes). Fifteen subjects will be enrolled in the study; specifically 15 male or female [more...]  patients 18 years of age or older with moderate to severe glabellar rhytids at maximum contracture. Each patient will be randomized to receive one of 5 doses of Xeomin®, either 20-, 40-, 60-, 80-, or 100 units, in a one-time dose to the treatment area. The efficacy endpoints will be determined by investigator and subject live assessment of the glabellar rhytids at rest and maximum contraction at each visit (every other day for 6 days post-injection, every month for 9 months following) using a validated 4 point photographic scale (minimal wrinkles [0], mild wrinkles [1], moderate wrinkles [2], or severe wrinkles [3]) used in previous studies. A written description of each photograph will be included to help standardize the application of the Photographic Scale.
Status: Recruiting Start Date: March 2012 Completion Date: April 2013
Cryo-Touch III Refinement Study Investigational Plan
This is a prospective, non-randomized study to evaluate the performance of the MyoScience Cryo-Touch III device for the treatment of glabellar and/or forehead wrinkles.
Status: Recruiting Start Date: June 2011 Completion Date: January 2013
Evaluation of Safety and Efficacy of Using Venus Freeze™ System for Wrinkles and Rhytides Treatment
Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis and hypodermis. Manifestations of the aging skin are among others: increased skin roughness (epidermis), skin dyschromia (epidermis, dermis): hyper and hypopigmentation, wrinkles and [more...]  elastosis - skin texture changes due to collagen modification, increased skin laxity and cellulite formation (dermis and hypodermis). Radio-frequency (RF) devices have been used for many years for a variety of surgical applications. The energy delivery systems of these established monopolar devices used a 'conductive coupling' delivery system in which energy is concentrated at the periphery of the electrode. While this was not of clinical significance for the incisional applications, it posed a problem for non-invasive rejuvenation as the accumulation of energy at the electrode's periphery would produce localized high concentrations of heat and burns. Venus Concept has developed the Venus Freeze™ system for wrinkles and rhytides treatment. The Venus Freeze™ system incorporates a power supply, RF generator and Magnetic Pulse Field technology, a computer controller and a treatment handpiece. The applicator allows selective heating of one or more target tissues (epidermis, dermis and hypodermis). While treating wrinkles and rhytides, the treatment creates enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis.
Status: Not yet recruiting Start Date: December 2010 Completion Date: March 2012
Effects of Oral and Topical Sea Buckthorn Oil Treatments on Skin Aging
The effect of oral supplementation of SBA24 sea buckthorn oil capsule and topical application of Omega7 sea buckthorn cream on skin ageing is studied in a single blind, parallel study.
Status: Not yet recruiting Start Date: October 2008 Completion Date: December 2008
Evaluation of Excessive UV Irradiation on Skin Aging by Multiphoton Laser Imaging and Biophysical Methods
In this study, test persons with chronic excessive UV radiation and a control group are examined by multiphoton laser imaging and biophysical methods in order to evaluate the dermal fiber network. We expect to observe signs of advanced skin aging in the test group.
Status: Not yet recruiting Start Date:  Completion Date: 
Efficacy and Safety of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
This study will confirm the efficacy and safety of a single topical administration of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines
Status: Active, not recruiting Start Date: August 2013 Completion Date: October 2013
Thermage CPT for Treatment of Facial and Neck Laxity
The purpose of this study to evaluate treatment with the Thermage CPT system for facial and neck laxity.
Status: Active, not recruiting Start Date: January 2013 Completion Date: December 2013
Onabotulinum Toxin Type A and Abobotulinum Toxin Type A Crow's Feet Rhytid Study
The objective of the study is to compare the time to onset of Dysport® versus Botox® in the treatment of lateral orbital rhytids ("crow's feet"). Thirty subjects were enrolled in the study; specifically 30 male or female patients 18 years or older with moderate [more...]  to severe lateral orbital rhytids at maximum contracture. Each patient were randomized to be treated with Dysport® on one side and Botox® on the other side. Both the injector and patient were blinded to the injected toxin. The efficacy endpoints were determined by investigator and subject live assessment of "crow's feet" at rest and maximum contraction at each visit (every other day for 6 days post-injection, every month for 9 months following) using a validated 5 point photographic scale(no wrinkles [0], very fine wrinkles [1], fine wrinkles [2], moderate wrinkles [3] or severe wrinkles [4]) used in previous studies. A written description of each photograph was included to help standardize the application of the Photographic Scale.
Status: Active, not recruiting Start Date: September 2009 Completion Date: February 2012
Autologous Fibroblast Grafts in Facial Skin Regeneration
The purpose of this study is to evaluate the presence of skin changes after grafting of autologous fibroblasts by means of biophysical, histological, immunohistological, gene expression, glycosaminoglycan, and sensitivity analyses.
Status: Active, not recruiting Start Date: March 2007 Completion Date: December 2012
Facial Cosmetic Acupuncture on Skin Rejuvenation
Facial Cosmetic Acupuncture technique includes wrinkles, acupoints and muscle points on the face, head and neck. This study is designed to determine the efficacy and safety of Facial Cosmetic Acupuncture on skin rejuvenation.
Status: Active, not recruiting Start Date: August 2011 Completion Date: 
A Study to Evaluate the Safety and Effectiveness of the Cryo-Touch II Device for the Treatment of Forehead and/or Glabellar Lines
A prospective, non-randomized, multicenter study to evaluate the safety and effectiveness of the cryo-touch II device for the treatment of forehead and/or glabellar lines
Status: Active, not recruiting Start Date: September 2011 Completion Date: May 2012
Safety and Efficacy Evaluation of Erbium Treatment
The purpose of this research study is to evaluate the safety and effectiveness of erbium lasers for dermatological cosmetic procedures.
Status: Active, not recruiting Start Date: July 2007 Completion Date: July 2009
Effect of DHEA on Skin Aging in Postmenopausal Women
The purpose of the study is to determine the response of skin parameters related to skin aging to the local action of DHEA in postmenopausal women.
Status: Active, not recruiting Start Date: November 2004 Completion Date: December 2005
To Evaluate the Safety and Efficacy of Botulax® Are Not Inferior to Those of Botox® in the Treatment of Glabellar Lines
To compare the safety and efficacy of Botulax® with Botox® in the improvement of moderate to severe glabellar lines.
Status: Completed Start Date: August 2011 Completion Date: March 2012
Efficacy and Safety Study of Botulinum Toxin Type A for Moderate to Severe Crow's Feet Lines
This study will evaluate the efficacy and safety of botulinum toxin type A compared to placebo control for the treatment of moderate to severe crow's feet lines.
Status: Completed Start Date: December 2012 Completion Date: May 2013
Efficacy and Safety Study of Botulinum Toxin Type A to Treat Glabellar Lines
The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of glabellar lines.
Status: Completed Start Date: November 2009 Completion Date: 
Evaluation of Safety and Efficacy of Using EndyMed Pro Skin Treatment System for Skin Wrinkle Treatment on Body Areas
Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis and hypodermis. Skin aging process involves among others: skin roughness (epidermis), skin dyschromia (epidermis, dermis), wrinkles and elastosis - skin texture changes due to [more...]  collagen modification, skin laxity and cellulite (dermis and hypodermis). EndyMed has developed the EndyMed Pro system - Computerized Radiofrequency System for Skin Tightening. By using a multielectrodes treatment tip an exact computerized thermal pattern can be produced allowing to selectively heating one or more of the target tissues (epidermis, dermis and hypodermis). In the skin tightening module the dermis and hypodermis would be targeted, creating enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis. This post marketing study is intended for evaluation of safety and efficacy of the EndyMed Pro system.
Status: Completed Start Date: November 2008 Completion Date: November 2009
Comparison of Outcome Parameters in Laser Rhytide Treatment
We previously published a comparative split-face study which has shown a significant, albeit moderate, effect of ablative fractional laser treatment. While indicating that a single session with fractional ablative lasers can be effective in the treatment of peri-orbital wrinkles, [more...]  the trial also revealed substantial disagreement between the different end points (profilometry, Fitzpatrick wrinkle score, patient satisfaction). Since the PBI is a patient-related index it could not be included in the aforementioned split-face trial; the present study therefore attempts to further elucidate the patient-related benefit of a single fractional ablative laser treatment session as well as carefully analyse the respective correlations between the outcome parameters employed.
Status: Completed Start Date: August 2008 Completion Date: March 2009
Clinical Trial to Assess Efficacy, Safety and Tolerability of Botulinum Toxin A (Xeomin®) in Treatment of Expression Wrinkles in the Upper Third of the Face
The purpose of this study is to determinate whether Xeomin® (Botulinum toxin Type A) is safe, effective and tolerable in woman aged 30 to 50 years old for treatment of mild, moderate or severe expression lines (wrinkles) in the upper third of the [more...]  face. The main outcome was the change in appearance of the wrinkles two weeks (visit 3) after product application as compared with baseline assessment.
Status: Completed Start Date: September 2009 Completion Date: November 2010
Comparison of Redermic, Rejuva-A and Combination of Both Redermic and Rejuva-A in Subjects With Signs of Aging
Facial skin aging is a complex process combining factors such as sun exposure, smoking and those that are believed to be inherited. Changes in the skin over time including decreased thickness result in skin atrophy, wrinkling, sagging, yellowness and changes in [more...]  pigmentation. Redermic is a cosmetic cream that has been evaluated clinically but not in comparison to tretinoin nor in combination with tretinoin. There is no data on the safety and efficacy of Redermic as compared to topical tretinoin. Rejuva is a cream currently approved by Health Canada for the treatment of photodamaged skin. It contains 0.025% tretinoin one of the most widely studied topical product for skin aging. Studies have shown that topical tretinoin increases collagen synthesis and epidermal thickness thereby improving the appearance of skin aging. The efficacy of Rejuva combined with another topical cosmetic cream such as Redermic in the treatment of skin aging is unknown. One hundred and twenty (120) subjects with signs of skin aging participated in this single-blind study to evaluate the efficacy and tolerance of Redermic versus Rejuva-A™ (0.025% tretinoin) and Redermic in combination with Rejuva-A™ (0.025% tretinoin).
Status: Completed Start Date: September 2009 Completion Date: July 2010
Evaluation of Safety and Efficacy of Using Imagine™ Computerized Radiofrequency System for Skin Tightening
Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis and hypodermis. Skin aging process involves among others: skin roughness (epidermis), skin dyschromia (epidermis, dermis), wrinkles and elastosis - skin texture changes due to [more...]  collagen modification, skin laxity and cellulite (dermis and hypodermis). EndyMion has developed the Imagine™ system - Computerized Radiofrequency System for Skin Tightening. By using a multielectrodes treatment tip an exact computerized thermal pattern can be produced allowing to selectively heating one or more of the target tissues (epidermis, dermis and hypodermis). In the skin tightening module the dermis and hypodermis would be targeted, creating enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis. This post marketing study is intended for evaluation of safety and efficacy of the Imagine™ system.
Status: Completed Start Date: July 2008 Completion Date: July 2009
Identification of Gene Biomarkers in Aging Skin
This study is a blinded, prospective, single-center, clinical study conducted in Japanese female subjects between the ages of 20-75 years. This design uses skin biopsy samples from environmentally exposed areas and unexposed (control) areas within the same subjects to [more...]  assess the gene expression profile from three different age groups.
Status: Completed Start Date: August 2008 Completion Date: April 2009
Patient Satisfaction With Treatment of BOTOX® Cosmetic for the Temporary Correction of Moderate to Severe Glabellar Lines
This study evaluates the patient satisfaction and onset of effect following treatment with botulinum toxin Type A in the treatment of glabellar rhytids (frown lines)
Status: Completed Start Date: March 2009 Completion Date: April 2009
Skin Safety Profile of Different Exposure to the Light Emitting Diode (LED) in Healthy Subjects
Photomodulation is a process which manipulates or regulates cell activity using light sources without thermal effect. Different studies have investigated the use of non-thermal low dose light emitting diode (LED) array for improving the appearance of photo aging damage. [more...]  The photomodulation concept includes a low energy, narrow band or coherent light with specific pulse sequences and durations. Preliminary investigations done by McDaniel et al. demonstrated that fibroblast activity could be regulated using pulsing light at specific wavelenghts. Using a variety of LED light sources, his group has demonstrated that by varying light pulses and other parameters, procollagen synthesis could be upregulated in human skin fibroblast culture [McDaniel DH, et al.Lasers Surg Med. 2002; 14-251]. A clinical correlation was also shown based on different clinical trials data on around 1000 subjects, LED has shown up to 90% improvement in wrinkles and an increase of collagen synthesis versus control with little or no side effects associated [Weiss, RA et al. Lasers Surg Med 2005; 36(2): 85-91- Weiss, RA et al.: J Drugs Dermatol 2004; 3(6): 605-610 - Weiss RA et al. Dermatol Surg 2005; 31(9):1999-1204 - Russel BA et al. J Cosmet Laser Ther 2005; 7 (3-4):196-200 - Bhat J et al. Laser Med Sci 2005; 20(1):6-10]. Based on these promising clinical data, Light BioScience submitted a dossier to the Food and Drug Administration (FDA) and obtained in January 2005 the FDA approval for its GentleWaves® Light Emitting Diode (LED) for the non-invasive treatment of periorbital (eye area) wrinkles and rhytids. The LED technology has been considered by FDA as non significant risk. In Europe, the GentleWaves® Light Emitting Diode has obtained the notified body certification for the same indication. This medical claim is associated with cosmetic improvement of aging and sun-damaged skin, further validation the science of LED photomodulation skin rejuvenation [Investigator's Brochure. Version 1]. This approval has been obtained with a professional LED GentleWaves® device used under a physician's responsibility. The initial regimen of 35 seconds twice per week with at least two days in between treatment for a total of 4 weeks duration of treatment has demonstrated efficacy for the treatment of typical signs of photo aging and no adverse effect. A monocentre, randomized clinical study.
Status: Completed Start Date: June 2008 Completion Date: December 2008
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Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Participants often receive the best healthcare available for their condition.

Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. Trials are federally regulated with strict guidelines to protect participants.

Skin Aging Clinical Trials Information presented on ClinicalTrialsSearch.org is not intended to be a substitute for qualified medical advice visit or treatment with a real physician. We are not physicians. Always consult with a medical doctor (MD). ClinicalTrialsSearch.org is a website dedicated to listing clinical research studies in human subjects, including those specifically related to Skin Aging. Clinical research trials and medical trials take place in hundreds of cities across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectiveness of new treatments and drugs. The purpose of the studies is to answer specific human health questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions. Clinical trials allow volunteers access to medical treatment options before they are available to the general public. Many times the participants receive treatment for free, and sometimes they are paid for their time. Participants often receive the best healthcare available possible for their condition. Risks are a reality, however, and may include more frequent doctor visits, health risks (possibly life-threatening), and/or the treatment being ineffective. U.S. - based Skin Aging studies are federally regulated with strict guidelines to protect patients.

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