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NCT05171556
IN-USE TOLERANCE STUDY UNDER DERMATOLOGICAL AND OPHTHALMOLOGICAL CONTROLS AND EFFICACY ASSESSMENT (Face Balm)
trial testing Cosmetic product in Hypersensitive in 33 participants. Completed in 11 May 2021.
11 May 2021
Quick facts
| Lead sponsor | Pierre Fabre Dermo Cosmetique |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 33 |
| Start date | 20 April 2021 |
| Primary completion | 11 May 2021 |
| Estimated completion | 11 May 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- Cosmetic product
Conditions studied
- Hypersensitive — all drugs for Hypersensitive →
- Reactive and Intolerant Skin — all drugs for Reactive and Intolerant Skin →
- Redness-prone Skin — all drugs for Redness-prone Skin →
- Stinger Subjects — all drugs for Stinger Subjects →
Sponsor
Pierre Fabre Dermo Cosmetique — full company profile →
Who can join
Adults 18 to 65, any sex, with Hypersensitive or Reactive and Intolerant Skin. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to assess the dermatological and ophthalmological tolerance of the investigational product Baume visage / Face balm RV4942A - RY1985 after 21 days of twice daily use on the study areas, under normal conditions of use. The aim of this study is also to: * evaluate the cutaneous sensitivity by a stinging test at D1 T0 and D22. * evaluate the cutaneous sensitivity by a sensitive scale at D1 T0, D1 Timm\*, D8 and D22. * evaluate the soothing efficacy by an efficacy questionnaire at D1 Timm\*, D8 and D22. * evaluate the cosmetic acceptability by a questionnaire at D22. This study is conducted as a national, monocentric, non-randomized open trial. The 33 subjects in this study (31 subjects on D22) present hypersensitive, reactive and intolerant skin on face. They are stinger subjects, with a dry to very dry skin. Timm\*: 10 to 30 minutes after first application
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05171556
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT04181177 — Efficacy Study of Cosmetic Product on Xerosis Induced by Systemic Anticancer Treatments · completed
- NCT04873089 — Efficacy Study of Cosmetic Product RV3278AET0943 Versus Non-treated Group in Adults With Oily and Acne Prone Skin · completed
Other Pierre Fabre Dermo Cosmetique trials
Trials by the same sponsor.
- NCT07014007 — Tolerance and Efficacy Open-label Study With RV4421B, in Various Populations With Atopic Dermatitis for 12 Weeks · NA · not yet recruiting
- NCT07166484 — Assessment of the Effect of the Product RV2666C Formula LA2984 Compared to an Untreated Area With an Epidermally Ablated · not yet recruiting
- NCT06983561 — Description of the Population With Moderate to Severe Atopic Dermatitis, Treated by Systemic Treatments and Needs Regard · recruiting
- NCT07341659 — Efficacy of Cosmetic Product RV3278B-OS0386 in the Maintenance Phase After Oral Isotretinoin Treatment of Adults Subject · NA · active not recruiting
- NCT06800755 — Evaluation of the Efficacy and Tolerance of the Medical Device RL3020-DP0364 in Adult Population With Stable Mild Plaque · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05171556 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pierre Fabre Dermo Cosmetique
- Last refreshed: 29 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05171556.
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