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

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.

Study Overview

• Status: Completed
• Conditions: Skin Aging
• Intervention / Treatment: Other: placebo cream; Other: colostrum cream

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Lodz, Poland, 90-419
    • Medical University of Lodz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: placebo cream; everyday using of placebo cream	Other: placebo cream; using a placebo cream
Active Comparator: colostrum cream; everyday using of colostrum cream	Other: colostrum cream; the intervention in our study is everyday using a cream with active ingridient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hydration	The skin was measured at standardized temperature and humidity using Courage + Khazaka electronic GmbH Multi Probe Adapter with the use of the aproporate probe. Hydratioan - measurement with corneometer, a capacitance method. The results are shown in in arbitrary units between 0 and 130. 1 CU =0,02 mg water in 1 cm2 epidermal stratum corneum	8 weeks
transepidermal water loss	The measurement is taken by Tewameter® TM probe: assessing transepidermal water loss. The results are shown in g/h/m2	8 weeks
erythema and melanin content	Mexameter® MX18 probe: measuring the level of hemoglobin (erythema) and melanin, the two main dyes responsible for skin color; a broad scale (0-999) of arbitrary Mexameter® units. The Mexameter ® MX 18 probe emits 3 specific light wavelengths. A receiver measures the reflection from the skin. As the quantity of emitted light is defined, the quantity of light absorbed by the skin can be calculated.	8 weeks
sebum	Sebumeter® SM 815 probe: measuring skin sebum level, independent of water content; results are shown as Sebumeter® units from 0-350 (approximated to μg/cm 2 in a certain range)	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
firmness of the skin	The skin was measured at standardized temperature and humidity using Courage + Khazaka electronic GmbH Multi Probe Adapter with the use of the following probe: Cutometer® MPA 580 probe: measuring the viscoelastic properties of the skin. R0 represents the passive response of the skin to force, lower values indicate greater firmness. First max. amplitude, highest point of the curve, this has an implication for the firmness of the skin. Results in mm. Lower values indicate more elastic skin.	8 weeks
firmness of the skin	F0 - firmness of the skin at the time of suction.Area dedicated to the firmness of the skin - the skin deformation under the negative pressure - changes in time - mm*s.	8 weeks

Collaborators and Investigators

• Sponsor: Medical University of Lodz

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): July 31, 2022

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: skin; TEWL; hydration; sheep colostrum; firmness; mature skin
• Other Study ID Numbers: RNN/275/21/KE; 503/3-066-02/503-31-001 (Other Grant/Funding Number: Medical University of Lodz)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data enclose photos of participants

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No