NCT06305923

The Efficacy of a Cosmetic Preparation Containing Sheep Colostrum on Mature Skin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Medical University of Lodz · Academic / Other
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to learn about colostrum as a cosmetic in mature skin. . The aim of the study was to examine the effect of a cosmetic preparation containing sheep colostrum on skin with signs of aging in mature women Participants will be given the creams and asked to apply one -two doses in the evening after nighttime facial cleaning. They were also asked to use sunscreens during the day. During the first visit and after eight weeks of everyday use of the tested cream, the skin parameters will be measured three times on both cheeks, and the results were averaged. Participants will be enrolled to the colostrum cream or base cream groups and will not be informed which group they belonged to.

Detailed description

Participants will be enrolled to the colostrum cream or base cream groups and will not be informed which group they belonged to. Participants will be given the creams and will be asked to apply one -two doses in the evening after nighttime facial cleaning. They will be also asked to use sunscreens during the day. 1. Instrumental Measurements of Skin Parameters During the first visit and after eight weeks of everyday use of the tested cream, the skin parameters will be measured three times on both cheeks, and the results will be averaged. The skin will be measured at standardized temperature and humidity using a Courage + Khazaka electronic GmbH Multi Probe Adapter with the use of the following probes: * Corneometer® CM825 probe: measuring skin hydration based on water content in the stratum corneum; * Tewameter® TM probe: assessing transepidermal water loss; * Mexameter® MX18 probe: measuring the level of hemoglobin (erythema) and mel-anin, the two main dyes responsible for skin color; * Sebumeter® SM 815 probe: measuring skin sebum level, independent of water con-tent; * Cutometer® MPA 580 probe: measuring the viscoelastic properties of the skin. The R0 and F0 parameters were chosen. R0 represents the passive response of the skin to force, lower values indicate greater firmness. F0 - firmness of the skin at the time of suction. Lower values indicate more elastic skin. 2. Photodocumentation The skin will be subjected to photodocumentation at the first and last visit with the use of the Photomedicus system. The photos will be taken in standard light and with stand-ardized face positions. The photos will be compared using the following scale: 0 means no improvement (the same as the initial picture), 1 - slight improvement, 2 - moderate improvement, 3 - marked improvement (marked improvement in appearance from the initial condition, but not completely optimal), 4 - greatest possible improvement (optimal aesthetic result). 3. Subjective assessment of the skin All participants, i.e. in both groups, subjectively will assess their skin condition after eight weeks of treatment. Participants will rate smoothing of shallow wrinkles, skin tone alignment, regeneration, hydration, elasticity, softness, redness reduction and hypersen-sitivity reduction; they will indicate either improvement, deterioration or no change. Finally, the results in each group will be presented as the percentage of subjects with improved, worsened or unchanged skin.

Conditions

• Skin Aging

Interventions

Type	Name	Description
OTHER	colostrum cream	the intervention in our study is everyday using a cream with active ingridient
OTHER	placebo cream	using a placebo cream

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-06-30
• Completion: 2022-07-31
• First posted: 2024-03-12
• Last updated: 2024-03-12

Locations

1 site across 1 country: Poland