Skin AgingCOLMATSKINNCT06305923
The Efficacy of a Cosmetic Preparation Containing Sheep Colostrum on Mature Skin
A study testing colostrum cream in people with Skin Aging, run by Medical University of Lodz at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- colostrum cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2022to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signs of skin aging: wrinkles, loss of skin elasticity, discolorations, dryness
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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.
- 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).
- 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
- Being tested
- colostrum cream, placebo cream
- Keywords
- sheep colostrum, skin, hydration, TEWL, firmness, mature skin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colostrum creamOther
the intervention in our study is everyday using a cream with active ingridient
placebo creamOther
using a placebo cream
| Study group | Role | What they receive |
|---|---|---|
| placebo cream | Placebo comparator | everyday using of placebo cream Receives: Other: placebo cream |
| colostrum cream | Active comparator | everyday using of colostrum cream Receives: Other: colostrum cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 Mar 2022
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305923
- Sponsor's protocol ID
- RNN/275/21/KE
- Other IDs
- 503/3-066-02/503-31-001
- Acronym
- COLMATSKIN
- Status last verified
- Feb 2024
- First submitted
- 22 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data enclose photos of participants
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Cosmetic Preparation Containing Sheep Colostrum on Mature Skin
- ClinicalTrials.gov ID
- NCT06305923
- Acronym / sponsor ID
- COLMATSKIN / RNN/275/21/KE
- Conditions
- Skin Aging
- Keywords
- sheep colostrum, skin, hydration, TEWL, firmness, mature skin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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).
- 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo cream | Placebo comparator | Other: placebo creameveryday using of placebo cream |
| colostrum cream | Active comparator | Other: colostrum creameveryday using of colostrum cream |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signs of skin aging: wrinkles, loss of skin elasticity, discolorations, dryness
- Signed informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colostrum creamthe intervention in our study is everyday using a cream with active ingridient | Other | colostrum cream |
| placebo creamusing a placebo cream | Other | placebo cream |
Primary outcome
hydration
Time frame: 8 weeks
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
transepidermal water loss
Time frame: 8 weeks
The measurement is taken by Tewameter® TM probe: assessing transepidermal water loss. The results are shown in g/h/m2
erythema and melanin content
Time frame: 8 weeks
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.
sebum
Time frame: 8 weeks
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)
2 secondary outcomes
firmness of the skin
Time frame: 8 weeks
firmness of the skin
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: Undecided. Data enclose photos of participants
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colostrum cream in people with Skin Aging, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hydration (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.