Private Clinic
Tehran, Tehran Province, Iran
NCT Number: NCT06844760
This study aimed to evaluate the safety and effectiveness of stabilized Hyaluronic Acid Injection under the brand name Perleux body for neck skin rejuvenation, elasticity improvement, and hydration enhancement.
Primary objective: Elasticity (R0, R2, and R5) improvement from baseline in neck area at weeks 8 and 16 Hypothesis: Perleux body (produced by Espad Pharmed Co.) has acceptable efficacy and safety profile for neck skin rejuvenation, elasticity improvement, and hydration enhancement.
Secondary objectives: Effectiveness and safety assessment of Perleux body Study design: This is a phase IV, single-arm, and pre-post study Setting: Subjects will be treated with 2cc of Perleux body at baseline. After 4 weeks, a touch-up injection will be performed to achieve optimal improvement.
Looking for future studies?
Notify Me35 year–60 year
All sexes
Interventional
Not applicable
Tehran, Tehran Province, Iran
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subjects will be treated with 2cc of Perleux body at baseline. After 4 weeks, a touch-up injection will be performed to achieve optimal improvement.
Time frame: weeks 8 and 16
Change of elasticity parameters (R0, R2, and R5) at weeks 8 and 16 from the baseline visit
Time frame: weeks 8 and 16
Change of stratum corneum moisture measured by MPA 580 probes in the neck area at weeks 8 and 16 from the baseline visit
Time frame: weeks 8 and 16
Change of TEWL measured by MPA 580 probes in the neck area at weeks 8 and 16 from the baseline visit
Time frame: weeks 8 and 16
Improvement in the clear lines and wrinkles of the neck area according to the Institut Biochimique SA (IBSA) Neck Laxity Scale, with grade 1 being normal tissue tone without noticeable laxity and grade 5 being severe laxity with extreme sagging, using before and after photos, by an independent physician
Time frame: weeks 8 and 16
Improvement in the clear lines and wrinkles of the neck area according to global aesthetic improvement scale (GAIS), with grade 1 being exceptional improvement and grade 5 being worsened, using before and after photos by an independent physician
Time frame: Day 0 and week 4
Pain intensity using the VAS (visual analogue scale) [from 0 (complete painlessness) to 10 (maximum pain imaginable)].
Time frame: weeks 8 and 16
Participant satisfaction by using the VAS [from 0 (complete dissatisfaction) to 10 (complete satisfaction)].
Time frame: weeks 8 and 16
Evaluation of participants on the improvement of their skin condition in terms of increased hydration, firmness and radiance, by a questionnaire designed by us. The questionnaire consists of five yes-or-no questions.
Time frame: Day 0 and weeks 4, 8, 16
Assessment of adverse events following treatment
Espad Pharmed
Industry
Evaluation of Effectiveness and Safety of Stabilized Injectable Hyaluronic Acid (Perleux Body, Produced by Espad Pharmed Company) in the Rejuvenation, Hydration, and Elasticity Improvement of the Neck Area
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07722351
Hyperpigmentation, Melanosis
Sosnowiec, Poland
View Trial DetailsNCT07564869
Facial Aging, Skin Aging
Winter Garden, Florida, United States
View Trial DetailsNCT07618468
Facial Wrinkles, Lipid Metabolism Disorders
Moscow, Russia
View Trial DetailsNCT07617350
Facial Lipoatrophy, Facial Wrinkles
Moscow, Russia
View Trial Details