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

NCT07695805 | Not Yet Recruiting

• 1 other identifier: PhDES2851B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Skin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

shower oleogel and body lotion

EXPERIMENTAL

shower oleogel and body lotion will be used daily for 28 days

Other: Shower oleogel and body lotion

shower gel and body lotion

ACTIVE COMPARATOR

shower gel and body lotion will be used daily for 28 days

Other: Shower gel and body lotion

Interventions

Shower oleogel and body lotion OTHER

Daily use of shower oleogel and body lotion for 28 days

shower oleogel and body lotion

Shower gel and body lotion OTHER

Daily use of shower gel and body lotion

shower gel and body lotion

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,…,
• 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,

Sponsors & Collaborators

• Lacer S.A.: lead

Study Sites (1)

PhD Trials

Lisbon, Lisbon District, 1750-182, Portugal

Location

Study Officials

• Perdo Contreiras

  PhD Trials

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Contreiras

CONTACT

+34 93 101 66 95; geral@phdtrials.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)