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Evaluation of the Effect of Combined Use of Cosmetic Products for Dry and Itchy Skin.

8. juli 2026 opdateret af: Lacer S.A.

Confirmation in Human Subjects of a Cosmetic Product Efficacy After Application in the Body Under Normal Conditions of Use.

The goal of this study is to learn if combined use of shower oleogel and body lotion works to improve skin itching and dryness in adults. It will also learn about its safety. The main question it aims to answer is:

• Does the products use improves skin hydration and itching? Researchers will compare shower oleogel and body lotion to a commercially available shower gel and the body lotion to see if the combined use is more efficient than use of body lotion alone.

Participants will:

  • Use assigned products every day for 1 month
  • Visit the CRO for checkups and tests on established schedule

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

    • Lisbon District
      • Lisbon, Lisbon District, Portugal, 1750-182

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion Criteria:

  • Age: 18-70 years old
  • Gender: both
  • Sensitive skin and 30% to 50% with atopic tendency (scored 8-12)
  • With dry or very dry skin on the body
  • With presence of itching due to different origins: contact/friction with fabrics, hard water, atopic tendency, dry skin, etc.

Exclusion Criteria:

  • cutaneous marks on the experimental areas, which could interfere with the assessment of skin reactions (pigmentation troubles, scar elements, over-developed pilosity, ephelides and naevi in too great quantity, sunburn),
  • allergy or reactivity to products of the same category than the tested one,
  • with history of malignant melanomas (Dubreullh melanosis…)
  • unbalanced hormonal treatment,
  • forecast of initiation of an hormonal treatment or change of the usual hormonal treatment during the study or 3 months before the starting of the study,
  • forecast of intensive sun or UVA exposure (UV lamps) during the test period,
  • breast-feeding or pregnancy,
  • treatment with Vitamin A acid or its derivatives stopped less than 3 months before the beginning of the study,
  • treatment with anti-stretch, firming, slimming or anti-cellulite products stopped less than 3 months before the beginning of the study,
  • diet stopped less than 3 months before the beginning of the study,
  • drugs likely to produce an increase or reduction in body weight,
  • under anti-cellulite treatment: mesotherapy, electrotherapy, ionisation, ultrasonotherapy, relaxation, acupuncture, hydrotherapy, lymphatic drainage, massage, sauna,…,
  • neither antibiotic, anti-allergic, anti-inflammatory treatment nor treatment with patent medicines containing Vitamin A acid or its derivatives before and during the study (if therapeutic requirement: exclusion foreseen),
  • systemic disorders: Cardiovascular, pulmonary, digestive, neurologic, psychiatric, genital, urinary, haematological, endocrine
  • individuals who have undergone a bilateral mastectomy with lymph node removal, a unilateral mastectomy with lymph node removal within the last year, or a bilateral axillary lymph node removal,
  • individuals with a history of immune deficiency or auto-immune disease, treated for malignancy within 6 months prior to enrollment or who are currently under treatment for asthma or diabetes,
  • forecast of vaccination during the test period or last vaccination within 3 weeks before the study

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: shower oleogel and body lotion
shower oleogel and body lotion will be used daily for 28 days
Daily use of shower oleogel and body lotion for 28 days
Aktiv komparator: shower gel and body lotion
shower gel and body lotion will be used daily for 28 days
Daily use of shower gel and body lotion

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Change from Baseline in the rate of skin hydration (capacitance measured by Corneometer) at 4 weeks
Tidsramme: From enrollment to the end of the study at 4 weeks
From enrollment to the end of the study at 4 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Change from Baseline in the rate of skin barrier function (TEWL evaluated by Tewameter) at 4 weeks.
Tidsramme: From enrollment to the end of the study at 4 weeks
From enrollment to the end of the study at 4 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Efterforskere

  • Ledende efterforsker: Perdo Contreiras, PhD Trials

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. september 2026

Studieafslutning (Anslået)

1. september 2026

Datoer for studieregistrering

Først indsendt

1. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

10. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • PhDES2851B

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Only summary of the results to support the publication will be shared. No complete study documents will be shared.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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