Health Condition 1: L99- Other disorders of skin and subcutaneous tissue in diseases classified elsewhere
Conditions
Interventions
Intervention1: Yuthbless cream: applied one time in a day
at night time
for 12 weeks
Control Intervention1: NIL: NIL
Sponsors
Zydus Healthcare limited
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 25 to 65 years of either gender All the patients who had more then and equal to 10 percentage body weight loss in the past 3 to 9 months on GLP-1 therapy or a comparable rapid weight loss with new or worsened facial hollowing and laxity confirmed by the investigator New or worsened facial hollowing and laxity confirmed by investigator at baseline Ability and willingness to participate and provide informed consent
Exclusion criteria
Exclusion criteria: All pregnant or lactating women All the patients with fillers or underwent for fat grafting threads RF/laser in the last 6 months All the patients using the systemic retinoids/Topical Retinoids or have used the systemic retinoids in the last 90 days All the patients with active facial dermatoses (eczema severe rosacea infections) All the patients with known hypersensitivity to the investigational product Any patient considered ineligible for the investigational product by the treating physician Patients unwilling to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Determine whether 12 weeks of daily treatment improves facial skin laxity and firmness compared with baselineTimepoint: at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Assess improvements in wrinkles hydration dryness flakiness dermal quality and patient perceived facial gauntness Assess safety and tolerabilityTimepoint: percent Improvement in depth of wrinkle or area of wrinkle at the end of 4 weeks 8 weeks and 12 weeks of treatment assessed via standardized digital image analysis percent Improvement in Hydration Index at the baseline end of 4 weeks 8 weeks and 12 weeks of treatment assessed by Hydration probe Change in Dryness Flakiness and sensitivity by investigator from baseline to Week 4 week 8 and week 12 as assessed by investigator scales Change in overall Investigator assessment from baseline to week 4 week 8 and week 12 Percent Improvement of Dermal thickness density at baseline 4 weeks 8 weeks and end of 12 weeks by high frequency ultrasound | — |
Countries
India
Contacts
Public ContactPratik shah
Zydus Healthcare Limited
Outcome results
None listed