Efficacy & Tolerance of Cosmetic Product RV5098A on Face Pigmentation Maintenance in Adult Vitiligo Patients.

Vitiligo Clinical Trial

Official title:

Efficacy and Tolerance of the Cosmetic Care Product RV5098A on the Maintenance of Pigmentation on Face in Adult Patients With Vitiligo.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06446063
• Other study ID #: RV5098A20230158
• Status: Recruiting
• Start date: May 23, 2024
• Est. completion date: June 1, 2025

Study information

• Verified date: May 2024
• Source: Pierre Fabre Dermo Cosmetique
• Contact: Christophe CHAMARD
• Phone: +335.34.50.65.88
• Email: christophe.chamard[@]pierre-fabre.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Vitiligo is an autoimmune depigmentation disorder affecting 0.5 to 1% of the population worldwide. Vitiligo lesions are characterized by a progressive loss of pigmentation caused by the disappearance of functioning melanocytes in the epidermis, mainly resulting from the activation of immune cells in a genetically predisposed patient.

Despite major advances in the understanding of the mechanisms of the disease, the treatment remains challenging. Different treatment strategies could lead to cosmetically acceptable repigmentation (>75%), particularly on face and neck. However, after repigmentation, the risk of relapse is estimated at nearly 40% during the first year after stopping treatment.

To date, long-term management remains a challenge. With their topical product RV5098A adapted for patients with vitiligo, Pierre Fabre Laboratories hypothesize that it could be effective in maintaining pigmentation of previously repigmented lesions in adults with facial vitiligo.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

Criteria related to the population:

• Subject aged between 18 and 75 years included.

Criteria related to the disease:

• Subject with facial vitiligo, regardless of its duration.

• having a sufficient repigmentation rate of the vitiligo after repigmenting treatment

Criteria related to treatments and/or products:

• Subject responder to a repigmenting treatment

Non-inclusion Criteria:

Criteria related to the diseases / skin condition:

• Subject with active vitiligo.

• Subject with spontaneous repigmentation without treatment.

• Subject having other dermatological condition, an acute, chronic, or progressive disease or history of disease liable to interfere with the study assessments or considered by the Investigator hazardous for the subject or incompatible with the study requirements.

Criteria related to treatments and/or products:

• Systemic immunomodulatory treatment taken for another pathology, before inclusion, on-going or planned to be established during the study.

• Any topical immunomodulatory treatment applied on the face for another pathology, on-going or planned to be established during the study.

• Any other topical or systemic treatment established or modified during the previous weeks or planned to be established or modified during the study, liable to interfere with the evaluation of the efficacy according to the investigator's assessment.

• Any dietary supplement for vitiligo within 4 weeks before the inclusion visit or planned to be established during the study.

Related Conditions & MeSH terms

• Vitiligo

Intervention

Other:
• Test product
Twice daily applications The product is applied to the entire face.
• Control Product
Twice daily applications The product is applied to the entire face.

Locations

Country	Name	City	State
France	COSDERMA	Bordeaux	Gironde

Sponsors (1)

Lead Sponsor	Collaborator
Pierre Fabre Dermo Cosmetique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo	assessed by the investigator on the face on a 7-point scale (from significant worsening to significant improvement)	assessed after 24 weeks of use
Secondary	Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo assessed by the investigator	assessed by the investigator on the face on a 7-point scale (from significant worsening to significant improvement)	assessed after 12 weeks of use
Secondary	Efficacy of the test product RV5098A on the maintenance of pigmentation by the global evolution of facial vitiligo assessed by the subject	assessed by the subject on the face on a 7-point scale (from very much worse to very much improved)	assessed after 12 and 24 weeks of use and monthly at home
Secondary	Efficacy of the test product RV5098A on the maintenance of pigmentation by the severity of facial vitiligo by the investigator	assessed by the investigator on the face on a vitiligo severity scale from 0 (absent) to 3 (complete depigmentation)	assessed at baseline and after 12 and 24 weeks of use.
Secondary	Efficacy of the test product RV5098A on the maintenance of pigmentation by the extent of facial vitiligo	assessed by the investigator on the face with score of extent of vitiligo	assessed at baseline and after 12 and 24 weeks of use.
Secondary	Efficacy of the test product RV5098A on the maintenance of pigmentation by the severity of facial vitiligo by the subject	assessed by the subject on the face on a 5-point scale (from no vitiligo to very severe)	assessed at baseline, after 12 and 24 weeks of use and monthly at home
Secondary	Efficacy of the test product RV5098A on the maintenance of pigmentation by the impact on quality of life assessed by the patient	assessed by the subject with quality-of-life questionnaire	assessed at baseline, after 12 and 24 weeks of use
Secondary	Efficacy of the test product RV5098A on the maintenance of pigmentation by imaging quantification.	Measurement of depigmentation surface on a target lesion of the face by the investigator.	assessed at baseline, after 12 and 24 weeks of use.
Secondary	Cosmetic satisfaction and perceived effects as regards to the use of the test product RV5098A by Cosmetic acceptability questionnaire assessed by the patient	A questionnaire with a scale from 0 to 10 responding to statements about the sensorial experience and effect of the product (0=not at all agree, 10=completely agree).	assessed after 12 and 24 weeks of use.
Secondary	Global tolerance of the test product RV5098A assessed by the investigator.	assessed by the investigator with 5-point scale (from bad to excellent)	assessed after 24 weeks of use.
Secondary	Compliance of the subjects to the test product RV5098A	The subject will report his/her compliance in a subject's diary	through study completion, 6 months