- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07695805
Evaluation of the Effect of Combined Use of Cosmetic Products for Dry and Itchy Skin.
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Contreiras
- Telefonnummer: +34 93 101 66 95
- E-post: geral@phdtrials.com
Studiesteder
-
-
Lisbon District
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Lisbon, Lisbon District, Portugal, 1750-182
- PhD Trials
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Ta kontakt med:
- Contreiras
- Telefonnummer: +34 93 101 66 95
- E-post: geral@phdtrials.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
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Hva måler studien?
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Perdo Contreiras, PhD Trials
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- PhDES2851B
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
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