Clinical trial NCT06305923: The Efficacy of a Cosmetic Preparation Containing Sheep Colostrum on Mature Skin
Official title: The Efficacy of a Cosmetic Preparation Containing Sheep Colostrum on Mature Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Aging
Keywords: sheep colostrum
skin
hydration
TEWL
firmness
mature skin
Lead sponsor: Medical University of Lodz
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 52
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Signs of skin aging: wrinkles, loss of skin elasticity, discolorations, dryness
* Signed informed consent

Exclusion Criteria:

* Pregnant or breastfeeding
* Allergic to milk proteins
* Suffer from neoplasms, contagious infections, autoimmunologic diseases
* Suffer from face skin diseases
* Have had an aesthetic procedure on the skin of the face during the last two months
* Have been treated with isotretinoin or other oral retinoids during the last six months

Primary outcomes:
measure: hydration
timeFrame: 8 weeks
measure: transepidermal water loss
timeFrame: 8 weeks
measure: erythema and melanin content
timeFrame: 8 weeks
measure: sebum
timeFrame: 8 weeks
Secondary outcomes:
measure: firmness of the skin
timeFrame: 8 weeks
measure: firmness of the skin
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Lodz
country: Poland
facility: Medical University of Lodz
Study officials:
References: