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

NCT06305923 | Completed

• 2 other identifiers: RNN/275/21/KE503/3-066-02/503-31-001
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Skin Aging

Keywords

sheep colostrum; skin; hydration; TEWL; firmness; mature skin

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• firmness of the skin

  8 weeks

• firmness of the skin

  8 weeks

Study Arms (2)

placebo cream

PLACEBO COMPARATOR

everyday using of placebo cream

Other: placebo cream

colostrum cream

ACTIVE COMPARATOR

everyday using of colostrum cream

Other: colostrum cream

Interventions

colostrum cream OTHER

the intervention in our study is everyday using a cream with active ingridient

colostrum cream

placebo cream OTHER

using a placebo cream

placebo cream

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Medical University of Lodz

Lodz, 90-419, Poland

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2022
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: March 12, 2024

Record last verified: 2024-02

Locations

PL (1)