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

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Skin
• Intervention / Treatment: Other: Shower oleogel and body lotion; Other: Shower gel and body lotion

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Contreiras; Phone Number: +34 93 101 66 95; Email: geral@phdtrials.com

Study Locations

• Portugal
  • Lisbon District
    • Lisbon, Lisbon District, Portugal, 1750-182
      • PhD Trials
      • Contact: Contreiras; Phone Number: +34 93 101 66 95; Email: geral@phdtrials.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: shower oleogel and body lotion; shower oleogel and body lotion will be used daily for 28 days	Other: Shower oleogel and body lotion; Daily use of shower oleogel and body lotion for 28 days
Active Comparator: shower gel and body lotion; shower gel and body lotion will be used daily for 28 days	Other: Shower gel and body lotion; Daily use of shower gel and body lotion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in the rate of skin hydration (capacitance measured by Corneometer) at 4 weeks	From enrollment to the end of the study at 4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from Baseline in the rate of skin barrier function (TEWL evaluated by Tewameter) at 4 weeks.	From enrollment to the end of the study at 4 weeks

Collaborators and Investigators

• Sponsor: Lacer S.A.
• Investigators: Principal Investigator: Perdo Contreiras, PhD Trials

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: July 1, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: PhDES2851B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only summary of the results to support the publication will be shared. No complete study documents will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No