Skin MicrobiomeNCT04759924
Mother - Newborn Observational Study
An observational study of Skin Microbiome, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Pregnancy leads to a number of skin changes but empirical evidence about the structural and functional changes of the skin is scarce. Findings on skin structure and function in newborns and children in the first year of life reveal a rapid skin maturation after birth, but evidence indicates, that in particular… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Skin Microbiome
- How many people
- 109 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2021to 26 Sep 2023
- Phase
- Observational
- 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 18 to 45 years
- Women only
- Adult
Study population: Pregnant women and their newborns
Who may be able to join
- written informed consent
- clinically healthy skin and hair appearance
- being free of any dermatological condition
- acceptance to abstain from sunbathing
- acceptance to abstain from solarium
- agreement to use the same skin cleaning and caring procedures during the study
Who cannot join
- regular smoking
- regular alcohol intake
- any dermatological condition or skin affection which may interfere with the study assessments (psoriasis, atopic dermatitis or other lesions at the investigational sites)
- clinically significant, possibly unstable medical conditions due to gravidity such as gestosis, eclampsia or thrombosis.
- Criteria related to treatments and products such as current topical or systemic treatment possibly affecting the skin, (diuretics, cholesterol-lowering drugs, hormones) during past four weeks
- therapeutic ultraviolet radiation within six weeks before inclusion
- increased ultraviolet-exposure within six weeks before inclusion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Skin Structure, Skin Function and Skin Microbiome of Pregnant Females and Their Newborns: a Descriptive Longitudinal Study
Pregnancy leads to a number of skin changes but empirical evidence about the structural and functional changes of the skin is scarce. Findings on skin structure and function in newborns and children in the first year of life reveal a rapid skin maturation after birth, but evidence indicates, that in particular water-holding and transport mechanisms are very different to adults in the first year in life. The most important open question is whether and how the maternal cutaneous properties predict the skin function of their children. This is especially relevant for the skin microbiome, because it closely interacts with the host and is assumed to play a role in many skin diseases. Therefore, the objective of this study is the description of characteristics of skin and hair structure and skin function of pregnant women and their newborns during pregnancy and for both in the first six months after delivery. In addition, we investigate associations of the mother's and their newborns skin microbiomes, and changes thereof in the newborns within the first six months of life.
The study has a descriptive, exploratory, longitudinal design. We will recruit pregnant females between 18 to 45 years old using advertisement campaigns, study information material in the waiting areas of their gynecologists, in pregnancy preparation services and in hospital's outpatient services. If they are interested and fulfill the inclusion criteria, they are invited to participate. Taking into account an assumed dropout rate of about 30%, a final sample of n = 100 women is expected. A detailed dermatological examination and general medical condition are documented. Non-invasive, standardized skin and hair physiological and skin microbiome measurements are performed during the visits. Baseline is scheduled during pregnancy until late 4 weeks before delivery. Follow-up visits are scheduled 4 weeks and 6 months after birth for mothers and newborns. Descriptive statistical methods will be calculated for frequencies and associations over time depending on scale levels of the measurements.
In our longitudinal study, we will characterize a broad range of individual and environmental characteristics of mothers and their newborns to evaluate interrelationships with skin parameters and their changes over the period of at least 8 months. Considering these multiple variables and levels together will allow a deeper understanding of the complex interrelationship of the newborns skin maturation.
Read the detailed description
A longitudinal descriptive, exploratory cohort study will be performed including females during pregnancy, puerperium and their newborns until sixth months of life.
Women will be invited after the first pregnancy trimester from the federal state of Berlin (Germany) during their visits to gynecologists and/or midwives. Inclusion and all study visits and measurement procedures will be conducted at the Clinical Research Center for Hair and Skin Science at the Department of Dermatology at the Charité-Universitätsmedizin Berlin (Germany). If meeting the eligibility criteria women will be included into the study. After inclusion into the study during the baseline visit, women will be followed at date of delivery + four weeks and followed further at the sixth month after delivery. The newborn/infants will be examined up to four weeks after birth and will be followed at sixth month after birth.
Due to the descriptive and exploratory nature of this study a broad range of characteristics and variables will be measured. Main aspects are skin structure, skin function and skin microbiome in one skin area. Skin structure will be measured by means of skin surface topography, epidermal thickness, skin stiffness and elasticity. Skin function will be measured by means of stratum corneum hydratation (SCH), TEWL and skin surface pH, which are established parameters to characterize the skin barrier function. Skin microbiome is defined as bacterial diversity, in detail the relative abundance of phylotypes, operational taxonomic units (OTU) will be measured. Hair growth will be measured on central and occipital scalp by means of hair density, hair widths.
- Conditions
- Skin Microbiome
- Keywords
- descriptive longitudinal study, skin structure, skin function, skin microbiome, hair growth, pregnancy, newborn
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline stratum corneum hydratation (SCH) at 4 weeks and 6 months after delivery
measurement of skin hydration: arbitrary units 0-120 , whereas higher readings indicate higher stratum corneum hydration
Measured: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Change from baseline Skin surface pH at 4 weeks and 6 months after delivery
Skin pH-meter measurement (range from 4 to 7,5)
Measured: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Change from baseline Transepidermal water loss (TEWL ) at 4 weeks and 6 months after delivery
Transepidermal waterloss through the stratum corneum in g per hour per m2 (range: 0,0-60,0 g/m2/h)
Measured: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Change from baseline Skin stiffness and elasticity at 4 weeks and 6 months after delivery
total extensibility (Uf, mm), Structural elasticity Uf) of the skin (0,00-0,50 Uf in mm/degree)
Measured: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Change from baseline Epidermal thickness at 4 weeks and 6 months after delivery
Standardized images via Optical coherence tomography (OCT) measured in mm
Measured: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Change from baseline Skin surface topography at 4 weeks and 6 months after delivery
Standardized images via Visioscan
- RA (arithmetic mean roughness) in µm
- RZ (arithmetic mean roughness from five sampling length) in µm
Measured: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Change from baseline Skin microbiome at 4 weeks and 6 months after delivery
Bacterial diversity Relative abundance of phylotypes (operational taxonomic units, (OTUs)
Measured: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Change from baseline Hair growth at 4 weeks and 6 months after delivery
Measurement of Hair thickness
Measured: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Mar 2021
- Primary completion26 Sep 2023
- Study completion26 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Skin MicrobiomeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrike Blume-Peytavi, MD, Charite University, Berlin, Germany
- Investigators
- Ulrike Blume-Peytavi, Prof. MD, Principal investigator, Charité Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759924
- Sponsor's protocol ID
- CRC-SP-AC-38
- Status last verified
- Feb 2024
- First submitted
- 3 Feb 2021
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Surber C, Dragicevic N, Kottner J. Skin Care Products for Healthy and Diseased Skin. Curr Probl Dermatol. 2018;54:183-200. doi: 10.1159/000489532. Epub 2018 Aug 21.
PubMed 30130786Muallem MM, Rubeiz NG. Physiological and biological skin changes in pregnancy. Clin Dermatol. 2006 Mar-Apr;24(2):80-3. doi: 10.1016/j.clindermatol.2005.10.002.
PubMed 16487877Vora RV, Gupta R, Mehta MJ, Chaudhari AH, Pilani AP, Patel N. Pregnancy and skin. J Family Med Prim Care. 2014 Oct-Dec;3(4):318-24. doi: 10.4103/2249-4863.148099.
PubMed 25657937Panicker VV, Riyaz N, Balachandran PK. A clinical study of cutaneous changes in pregnancy. J Epidemiol Glob Health. 2017 Mar;7(1):63-70. doi: 10.1016/j.jegh.2016.10.002. Epub 2016 Nov 19.
PubMed 27870929Ciechanowicz P, Sikora M, Taradaj K, Ruta A, Rakowska A, Kociszewska-Najman B, Wielgos M, Rudnicka L. Skin changes during pregnancy. Is that an important issue for pregnant women? Ginekol Pol. 2018;89(8):449-52. doi: 10.5603/GP.a2018.0077.
PubMed 30215465Martins-Costa GM, Bakos R. Total Body Photography and Sequential Digital Dermoscopy in Pregnant Women. Dermatol Pract Concept. 2019 Apr 30;9(2):126-131. doi: 10.5826/dpc.0902a08. eCollection 2019 Apr.
PubMed 31106015Thom E. Pregnancy and the hair growth cycle: anagen induction against hair growth disruption using Nourkrin(R) with Marilex(R) , a proteoglycan replacement therapy. J Cosmet Dermatol. 2017 Sep;16(3):421-427. doi: 10.1111/jocd.12286. Epub 2016 Sep 23.
PubMed 27659896Pierard-Franchimont C, Pierard GE. Alterations in hair follicle dynamics in women. Biomed Res Int. 2013;2013:957432. doi: 10.1155/2013/957432. Epub 2013 Dec 24.
PubMed 24455742Boyer G, Lachmann N, Bellemere G, De Belilovsky C, Baudouin C. Effects of pregnancy on skin properties: A biomechanical approach. Skin Res Technol. 2018 Nov;24(4):551-556. doi: 10.1111/srt.12465. Epub 2018 Feb 26.
PubMed 29479745Ludriksone L, Garcia Bartels N, Kanti V, Blume-Peytavi U, Kottner J. Skin barrier function in infancy: a systematic review. Arch Dermatol Res. 2014 Sep;306(7):591-9. doi: 10.1007/s00403-014-1458-6. Epub 2014 Mar 5.
PubMed 24595645Nikolovski J, Stamatas GN, Kollias N, Wiegand BC. Barrier function and water-holding and transport properties of infant stratum corneum are different from adult and continue to develop through the first year of life. J Invest Dermatol. 2008 Jul;128(7):1728-36. doi: 10.1038/sj.jid.5701239. Epub 2008 Jan 17.
PubMed 18200056Visscher MO, Adam R, Brink S, Odio M. Newborn infant skin: physiology, development, and care. Clin Dermatol. 2015 May-Jun;33(3):271-80. doi: 10.1016/j.clindermatol.2014.12.003. Epub 2014 Dec 8.
PubMed 25889127Oranges T, Dini V, Romanelli M. Skin Physiology of the Neonate and Infant: Clinical Implications. Adv Wound Care (New Rochelle). 2015 Oct 1;4(10):587-595. doi: 10.1089/wound.2015.0642.
PubMed 26487977Hughes-Formella B, Wunderlich O, Williams R, Fernandez J, Kim YZ, Wigger-Alberti W, Pecquet S, Moodycliffe A. Comparison of Skin Structural and Functional Parameters in Well-Nourished and Moderately Undernourished Infants. Skin Pharmacol Physiol. 2019;32(4):212-223. doi: 10.1159/000499434. Epub 2019 Jun 5.
PubMed 31167217Fluhr JW, Darlenski R. Skin Surface pH in Newborns: Origin and Consequences. Curr Probl Dermatol. 2018;54:26-32. doi: 10.1159/000489515. Epub 2018 Aug 21.
PubMed 30130770
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Structure, Skin Function and Skin Microbiome of Pregnant Females and Their Newborns: a Descriptive Longitudinal Study
- ClinicalTrials.gov ID
- NCT04759924
- Acronym / sponsor ID
- CRC-SP-AC-38
- Conditions
- Skin Microbiome
- Keywords
- descriptive longitudinal study, skin structure, skin function, skin microbiome, hair growth, pregnancy, newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 26 Sep 2023 (actual)
- Study completion
- 26 Sep 2023 (actual)
- First posted
- 18 Feb 2021 (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.
Pregnancy leads to a number of skin changes but empirical evidence about the structural and functional changes of the skin is scarce. Findings on skin structure and function in newborns and children in the first year of life reveal a rapid skin maturation after birth, but evidence indicates, that in particular water-holding and transport mechanisms are very different to adults in the first year in life. The most important open question is whether and how the maternal cutaneous properties predict the skin function of their children. This is especially relevant for the skin microbiome, because it closely interacts with the host and is assumed to play a role in many skin diseases. Therefore, the objective of this study is the description of characteristics of skin and hair structure and skin function of pregnant women and their newborns during pregnancy and for both in the first six months after delivery. In addition, we investigate associations of the mother's and their newborns skin microbiomes, and changes thereof in the newborns within the first six months of life.
The study has a descriptive, exploratory, longitudinal design. We will recruit pregnant females between 18 to 45 years old using advertisement campaigns, study information material in the waiting areas of their gynecologists, in pregnancy preparation services and in hospital's outpatient services. If they are interested and fulfill the inclusion criteria, they are invited to participate. Taking into account an assumed dropout rate of about 30%, a final sample of n = 100 women is expected. A detailed dermatological examination and general medical condition are documented. Non-invasive, standardized skin and hair physiological and skin microbiome measurements are performed during the visits. Baseline is scheduled during pregnancy until late 4 weeks before delivery. Follow-up visits are scheduled 4 weeks and 6 months after birth for mothers and newborns. Descriptive statistical methods will be calculated for frequencies and associations over time depending on scale levels of the measurements.
In our longitudinal study, we will characterize a broad range of individual and environmental characteristics of mothers and their newborns to evaluate interrelationships with skin parameters and their changes over the period of at least 8 months. Considering these multiple variables and levels together will allow a deeper understanding of the complex interrelationship of the newborns skin maturation.
Detailed description
A longitudinal descriptive, exploratory cohort study will be performed including females during pregnancy, puerperium and their newborns until sixth months of life.
Women will be invited after the first pregnancy trimester from the federal state of Berlin (Germany) during their visits to gynecologists and/or midwives. Inclusion and all study visits and measurement procedures will be conducted at the Clinical Research Center for Hair and Skin Science at the Department of Dermatology at the Charité-Universitätsmedizin Berlin (Germany). If meeting the eligibility criteria women will be included into the study. After inclusion into the study during the baseline visit, women will be followed at date of delivery + four weeks and followed further at the sixth month after delivery. The newborn/infants will be examined up to four weeks after birth and will be followed at sixth month after birth.
Due to the descriptive and exploratory nature of this study a broad range of characteristics and variables will be measured. Main aspects are skin structure, skin function and skin microbiome in one skin area. Skin structure will be measured by means of skin surface topography, epidermal thickness, skin stiffness and elasticity. Skin function will be measured by means of stratum corneum hydratation (SCH), TEWL and skin surface pH, which are established parameters to characterize the skin barrier function. Skin microbiome is defined as bacterial diversity, in detail the relative abundance of phylotypes, operational taxonomic units (OTU) will be measured. Hair growth will be measured on central and occipital scalp by means of hair density, hair widths.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women and their newborns
Key inclusion criteria (6 listed)
- written informed consent
- clinically healthy skin and hair appearance
- being free of any dermatological condition
- acceptance to abstain from sunbathing
- acceptance to abstain from solarium
Key exclusion criteria (7 listed)
- regular smoking
- regular alcohol intake
- any dermatological condition or skin affection which may interfere with the study assessments (psoriasis, atopic dermatitis or other lesions at the investigational sites)
- clinically significant, possibly unstable medical conditions due to gravidity such as gestosis, eclampsia or thrombosis.
- Criteria related to treatments and products such as current topical or systemic treatment possibly affecting the skin, (diuretics, cholesterol-lowering drugs, hormones) during past four weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change from baseline stratum corneum hydratation (SCH) at 4 weeks and 6 months after delivery
Time frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
measurement of skin hydration: arbitrary units 0-120 , whereas higher readings indicate higher stratum corneum hydration
Change from baseline Skin surface pH at 4 weeks and 6 months after delivery
Time frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Skin pH-meter measurement (range from 4 to 7,5)
Change from baseline Transepidermal water loss (TEWL ) at 4 weeks and 6 months after delivery
Time frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Transepidermal waterloss through the stratum corneum in g per hour per m2 (range: 0,0-60,0 g/m2/h)
Change from baseline Skin stiffness and elasticity at 4 weeks and 6 months after delivery
Time frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
total extensibility (Uf, mm), Structural elasticity Uf) of the skin (0,00-0,50 Uf in mm/degree)
Change from baseline Epidermal thickness at 4 weeks and 6 months after delivery
Time frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Standardized images via Optical coherence tomography (OCT) measured in mm
Change from baseline Skin surface topography at 4 weeks and 6 months after delivery
Time frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Standardized images via Visioscan * RA (arithmetic mean roughness) in µm * RZ (arithmetic mean roughness from five sampling length) in µm
Change from baseline Skin microbiome at 4 weeks and 6 months after delivery
Time frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Bacterial diversity Relative abundance of phylotypes (operational taxonomic units, (OTUs)
Change from baseline Hair growth at 4 weeks and 6 months after delivery
Time frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery
Measurement of Hair thickness
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 9 Feb 2024.
- Background: PubMed 30130786Surber C, Dragicevic N, Kottner J. Skin Care Products for Healthy and Diseased Skin. Curr Probl Dermatol. 2018;54:183-200. doi: 10.1159/000489532. Epub 2018 Aug 21.
- Background: PubMed 16487877Muallem MM, Rubeiz NG. Physiological and biological skin changes in pregnancy. Clin Dermatol. 2006 Mar-Apr;24(2):80-3. doi: 10.1016/j.clindermatol.2005.10.002.
- Background: PubMed 25657937Vora RV, Gupta R, Mehta MJ, Chaudhari AH, Pilani AP, Patel N. Pregnancy and skin. J Family Med Prim Care. 2014 Oct-Dec;3(4):318-24. doi: 10.4103/2249-4863.148099.
- Background: PubMed 27870929Panicker VV, Riyaz N, Balachandran PK. A clinical study of cutaneous changes in pregnancy. J Epidemiol Glob Health. 2017 Mar;7(1):63-70. doi: 10.1016/j.jegh.2016.10.002. Epub 2016 Nov 19.
- Background: PubMed 30215465Ciechanowicz P, Sikora M, Taradaj K, Ruta A, Rakowska A, Kociszewska-Najman B, Wielgos M, Rudnicka L. Skin changes during pregnancy. Is that an important issue for pregnant women? Ginekol Pol. 2018;89(8):449-52. doi: 10.5603/GP.a2018.0077.
- Background: PubMed 31106015Martins-Costa GM, Bakos R. Total Body Photography and Sequential Digital Dermoscopy in Pregnant Women. Dermatol Pract Concept. 2019 Apr 30;9(2):126-131. doi: 10.5826/dpc.0902a08. eCollection 2019 Apr.
- Background: PubMed 27659896Thom E. Pregnancy and the hair growth cycle: anagen induction against hair growth disruption using Nourkrin(R) with Marilex(R) , a proteoglycan replacement therapy. J Cosmet Dermatol. 2017 Sep;16(3):421-427. doi: 10.1111/jocd.12286. Epub 2016 Sep 23.
- Background: PubMed 24455742Pierard-Franchimont C, Pierard GE. Alterations in hair follicle dynamics in women. Biomed Res Int. 2013;2013:957432. doi: 10.1155/2013/957432. Epub 2013 Dec 24.
- Background: PubMed 29479745Boyer G, Lachmann N, Bellemere G, De Belilovsky C, Baudouin C. Effects of pregnancy on skin properties: A biomechanical approach. Skin Res Technol. 2018 Nov;24(4):551-556. doi: 10.1111/srt.12465. Epub 2018 Feb 26.
- Background: PubMed 24595645Ludriksone L, Garcia Bartels N, Kanti V, Blume-Peytavi U, Kottner J. Skin barrier function in infancy: a systematic review. Arch Dermatol Res. 2014 Sep;306(7):591-9. doi: 10.1007/s00403-014-1458-6. Epub 2014 Mar 5.
- Background: PubMed 18200056Nikolovski J, Stamatas GN, Kollias N, Wiegand BC. Barrier function and water-holding and transport properties of infant stratum corneum are different from adult and continue to develop through the first year of life. J Invest Dermatol. 2008 Jul;128(7):1728-36. doi: 10.1038/sj.jid.5701239. Epub 2008 Jan 17.
- Background: PubMed 25889127Visscher MO, Adam R, Brink S, Odio M. Newborn infant skin: physiology, development, and care. Clin Dermatol. 2015 May-Jun;33(3):271-80. doi: 10.1016/j.clindermatol.2014.12.003. Epub 2014 Dec 8.
- Individual participant dataSharing planned: No
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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.
Ulrike Blume-Peytavi, Prof. MD principal investigator
Charité Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Microbiome, run by Charite University, Berlin, Germany at 1 site in Germany.
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 6 inclusion and 7 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 9 Feb 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 Germany. 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. 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?
Change from baseline stratum corneum hydratation (SCH) at 4 weeks and 6 months after delivery (time frame: baseline visit mother at least 4 weeks before delivery, mother and newborn: 4 weeks and 6 months after delivery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04759924, which also lists 24 linked publications.
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 9 Feb 2024.