Toleriane Ultra Reno in Allergic Subjects With Skin Intolerance to Their Usual Cosmetic

NCT05487937 | Completed

• 1 other identifier: LRP20006-TOLERIANE ULTRA
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

Sensitive skin is a subjective cutaneous hyper-reactivity to environmental factors. People report exaggerated reactions when their skin, especially on the face, is in contact with substances such as cosmetics. For this reason, Toleriane Ultra has been developed to limit the risk of allergy and relieve skin discomfort. The study aims at demonstrating that Toleriane Ultra is well tolerated in participants with allergic background and having experienced former intolerance to their cosmetic or toiletries routine, and improves skin sensitivity in such individuals. This open-labeled, multicenter study was conducted under dermatological control in Caucasian subjects above 16 years of age with an allergic background and intolerance to cosmetics lasting for at least 2 years prior to inclusion. The dermocosmetic product was to be applied on the entire face twice daily for 28 days.

Conditions

Allergy

Keywords

allergy; intolerance; dermocosmetic; allergic

Outcome Measures

Primary Outcomes (6)

• change in cutaneous acceptability

  evaluation of global tolerance by investigator and participants on a 4-point scale

  Change from baseline to Day28

• change in cutaneous reactivity score

  cutaneous reactivity score on a 4-point scale (non stinging, mild stinging sensation, moderate stinging sensation, severe stinging sensation) before and after product use with a stinging test

  Change from baseline to Day28

• change in Sensiscore

  questionnaire on frequency and intensity of functional signs on the face by self-assessment on a 5-point scale

  Change from baseline to Day28

• change in composite score

  questionnaire on pruritus, redness, burning and tingling by self-assessment on a 4-point scale

  Change from baseline to Day28

• change in transepidermal water loss

  transepidermal water loss measurements before and after product use with a Tewameter

  Change from baseline to Day28

• change in the hydration rate

  hydration rate before and after product use with a Corneometer

  Change from baseline to Day28

Study Arms (1)

Toleriane Ultra

Participants are asked to apply the study product twice daily (morning and evening) at home for 28 days.

Other: Use of Toleriane Ultra to relieve face allergic skin

Interventions

Use of Toleriane Ultra to relieve face allergic skin OTHER

The product developed to restore the natural skin barrier and rebalance skin immune system is a white cream and is applied on the face by a slight massage under normal conditions of use twice daily for 28 days.

Toleriane Ultra

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

participants meeting the inclusion and exclusion criteria and accepting the study constraints

You may qualify if:

• years old and above
• caucasian
• phototype I to IV
• participants presenting with an allergy ground
• participants having skin intolerance with cosmetic care
• participants who have not changed their cosmetic habits for less than 15 days

You may not qualify if:

• for women: pregnant or nursing or planning a pregnancy during the study
• cutaneous pathology on the studied zone
• use of topical or systemic treatment during the previous weeks liable to interfere with assessment of the cutaneous acceptability of the study product
• professional facial care during the study or within the previous month
• excessive exposure to sunlight or UV-rays within the previous month
• participant having undergone surgery under general anesthesia within the previous month

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

Dermscan Poland Sp. z o. o.

Gdansk, 80-288, Poland

Location

Related Publications (1)

• Kerob D, Czermanska A, Karamon EM, Moga A, Lecerf G, Niore M, Le Dantec G, Le Floc'h C, Tan J. A Dermocosmetic Significantly Reduces the Frequency and Intensity of Facial Skin Intolerability and Sensitivity in Subjects with Skin Intolerant to Skin Care Products and Sensitive Skin. Clin Cosmet Investig Dermatol. 2023 Jul 11;16:1787-1794. doi: 10.2147/CCID.S418483. eCollection 2023.

  PMID: 37456802 DERIVED

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Anna Czermanska

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: August 4, 2022
• Study Start: May 25, 2021
• Primary Completion: September 28, 2021
• Study Completion: September 28, 2021
• Last Updated: August 4, 2022

Record last verified: 2022-08

Locations

PL (1)