Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

A Double-Blind, Randomized, Double-Dummy, Active and Placebo-Controlled Clinical Study to Assess the Effect of an Oral Skin Supplement on Skin Health in Healthy Adults

28. juli 2026 oppdatert av: Amazentis SA
The aim of this study is to investigate the impact of a two skin from within nutritional supplement(s) compared to placebo on skin aging biomarker changes.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

90

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Male and female trial participants in the age group of 35 -65 years, both ages inclusive.
  2. Trial participants in good general health, as determined by the Investigator based on medical history, physical examination, vital signs, and clinical laboratory evaluations (CBC, LFT, and RFT).
  3. Trial participants presenting with visible signs of facial skin aging, as assessed by the Investigator.
  4. Trial participants willing to consume the assigned study products daily for 8 weeks in accordance with the study protocol.
  5. Trial participants must be willing to undergo two minimally invasive skin biopsies collected from the upper arms.
  6. Trial participants must be willing to provide blood samples for plasma collection and laboratory Investigations.
  7. Trial participants willing to refrain from initiating any new skin care products, oral supplements, or anti-aging treatments during the study.
  8. Trial participants willing to maintain their permitted and restricted skincare, diet, and lifestyle habits throughout the study.
  9. Trial participants free of excessive hair, acne, cuts, abrasions, fissures, wounds, lacerations, or any other active skin conditions on the face and upper arms as determined by the dermatologist.
  10. Trial participants who agree not to have direct and excessive sun exposure (not more than half an hour daily and during that time use of umbrella to cover face and upper arms).
  11. Trial participants willing to refrain from bleaching or any other procedures including facial etc. on face during the study period.
  12. Trial participants willing to give a voluntary written informed consent, photography release and agree to come for regular follow-up.
  13. Trial participants willing to abide by and comply with study protocol.

Exclusion Criteria:

  1. Trial participants with known allergy, hypersensitivity, or intolerance to the study products or any of their ingredients, which, in the opinion of the Investigator, may impact participant safety, skin condition, or study outcomes.
  2. Trial participants with clinical non-significant laboratory values or clinically significant findings in CBC, LFT, or RFT that, in the opinion of the Investigator, may affect participant safety or study participation.
  3. Trial participants with a history or presence of clinically significant systemic diseases, including cardiovascular, immunological, vascular, hepatic, gallbladder, renal, or other uncontrolled medical disorders that, in the opinion of the Investigator, may interfere with study participation or study assessments.
  4. Trial participants with active dermatological conditions on the face, including eczema, psoriasis, rosacea, acne, dermatitis, infections, wounds, sunburn, scars, or other skin disorders that may interfere with study assessments.
  5. Trial participants who have used anti-aging treatments or procedures, including retinoids, isotretinoin, topical, systemic, injectable, or device-based therapies, within 3 months prior to screening.
  6. Trial participants currently taking any medication that, in the opinion of the Investigator, may affect study results or interfere with study participation.
  7. Trial participants who have undergone facial cosmetic procedures or aesthetic treatments, including chemical peels, laser treatments, dermabrasion, microneedling, botulinum toxin injections, dermal fillers, or similar procedures within 3 months prior to screening.
  8. Trial participants currently using or having used within 1 month prior to screening oral supplements or medications known to influence skin appearance or aging (e.g., collagen supplements, biotin, antioxidant supplements, or investigational products).
  9. Trial participants with a history of keloid formation, hypertrophic scarring, poor wound healing, bleeding disorders, or active skin infection, inflammation, wounds, or other abnormal skin conditions at or near the planned biopsy site.
  10. Trial participants with a known bleeding disorder or current use of anticoagulant/antiplatelet medications that may interfere with blood collection.
  11. Trial participants who have participated in another similar clinical trial within 3 months prior to screening.
  12. Female trial participants who are pregnant, breastfeeding, or planning pregnancy during the study period.
  13. Trial participants with a history of smoking, current smoking, use of smokeless tobacco products, or a history of or ongoing alcohol or recreational drug abuse.
  14. Trial participants who are employees of the Sponsor, Contract Research Organization (CRO), or study site directly involved in the conduct of the study.
  15. Trial participants judged by the Investigator to be unsuitable for participation for any reason that may compromise participant safety, protocol compliance, or study integrity.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Grunnvitenskap
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Food supplement placebo
The food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products
Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water.
Aktiv komparator: Food supplement Active
Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water.
The food supplement active supplement (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products
Sham-komparator: Food supplement Comparator
The food supplement placebo (2 soft gels) will be consumed once per day with a large glass of water. Also, a supplement placebo powder will be provided to double-mask the 2 active products
Active supplement comparator powder will be provided (20g) to be consumed once per day in a glass of water. The food supplement placebo (2 soft gels) will also be consumed once per day with a large glass of water to double-mask the trial.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Skin aging hallmarks
Tidsramme: 8 weeks
Change from baseline in skin hallmarks of aging (assessed on 2X2mm punch skin biopsies) after 8 weeks in a subpanel of participants
8 weeks

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Forekomst av uønskede hendelser
Tidsramme: 8 uker
8 uker
Dermatological Assessments of Skin Health (Photo-grading using VISIA imaging)
Tidsramme: 8 weeks
To evaluate and compare the efficacy of the test product with baseline and an active comparator in improving facial skin health as assessed with photoimaging (VISIA)
8 weeks
changes in circulating levels of Urolithin A in plasma samples of participants by bioanalytical assessments.
Tidsramme: 8 weeks
8 weeks

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Samarbeidspartnere

Etterforskere

  • Studieleder: Dr. Mukta Sachdev, MD, MS Clinical Research Pvt. Ltd

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

4. august 2026

Primær fullføring (Antatt)

30. juni 2027

Studiet fullført (Antatt)

31. august 2027

Datoer for studieregistrering

Først innsendt

28. juli 2026

Først innsendt som oppfylte QC-kriteriene

28. juli 2026

Først lagt ut (Faktiske)

3. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

3. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • SKIN/TLSS/2026-01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .