Evaluation of the Efficacy of SeS2 Shampoo on Subjects Having Dandruff

NCT05506592 | Unknown DMC

• 1 other identifier: ACR_VICO_1411
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

A shampoo containing SeS2 was evaluated versus placebo on healthy subjects suffering from dandruff in order to assess clinical benefits and its impact on fungal and bacterial scalp microbiota.

Conditions

Dandruff

Keywords

Squamous; Malassezia; bacteria

Outcome Measures

Primary Outcomes (4)

• Analysis of microflora from swabs for fungi quantification

  malassezia qPCR

  1 month

• Analysis of microflora from swabs for bacteria quantification

  Cutibacterium qPCR

  1 month

• Analysis of microflora from swabs for bacteria diversity

  sequencing 16S

  1 month

• Analysis of microflora from swabs for fungi diversity

  sequencing ITS

  1 month

Secondary Outcomes (1)

• Grading of Dandruff severity

  1 month

Other Outcomes (5)

• Clinical assessment of oily aspect of the scalp

  1 month

• Clinical assessment of erythema

  1 month

• Self-perception of efficacy: dandruff

  1 month

Study Arms (2)

Selenium disulfide shampoo

ACTIVE COMPARATOR

Other: dermatological product

placebo shampoo

PLACEBO COMPARATOR

Other: dermatological product

Interventions

dermatological product OTHER

cosmetic shampoo

Selenium disulfide shampoo; placebo shampoo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female volunteers;
• Age: 18 to 60 years old included;
• Phototype (Fitzpatrick): I to IV;
• Subjects with hair length \> 2 cm, and preferentially shorter than shoulder length;
• Females of childbearing potential, who are sexually actives, using an effective contraceptive method\* for at least one month before the beginning of the study, and throughout the study;
• Subjects exhibiting moderate to severe dandruff status of scalp at screening
• total dandruff score (adherent + non-adherent) \> or = 4.5 (ranging from 0 to 10);
• adherent dandruff score \> or = 2.5 (ranging from 0 to 5);
• no limit for non-adherent dandruff score;
• Subjects usually using a shampoo 3 times/week and willing to have three times/week shampoos during the course of the study;
• Subjects agreeing to use only the supplied shampoo during all the study;
• Subjects agreeing to have 4 hair areas on the scalp (2 areas of approximately 2 cm x 2 cm and 2 areas approximately 1cmx1cm) for micro flora sample taking (swabs);
• Subjects agreeing to have hair cut around the 4 identified areas (zone of 1x0.5cm cut on the high corner of each area sampling)
• Subjects who demonstrate understanding of the study and willingness to participate as evidenced by voluntary written informed consent and have received a signed and dated copy of the informed consent form.
• Subject affiliated to a social security or insurance system;

You may not qualify if:

• Healthy male or female volunteers;
• Age: 18 to 60 years old included;
• Phototype (Fitzpatrick): I to IV;
• Subjects with hair length \> 2 cm, and preferentially shorter than shoulder length;
• Females of childbearing potential, who are sexually actives, using an effective contraceptive method\* for at least one month before the beginning of the study, and throughout the study;
• Subjects exhibiting moderate to severe dandruff status of scalp at screening and at D-3;
• total dandruff score (adherent + non-adherent) \> or = 4.5 (ranging from 0 to 10);
• adherent dandruff score \> or = 2.5 (ranging from 0 to 5);
• no limit for non-adherent dandruff score;
• Subjects usually using a shampoo 3 times/week and willing to have three times/week shampoos during the course of the study;
• Subjects agreeing to use only the supplied shampoo during all the study;
• Subjects agreeing to have 4 hair areas on the scalp (2 areas of approximately 2 cm x 2 cm and 2 areas approximately 1cmx1cm) for micro flora sample taking (swabs);
• Subjects agreeing to have hair cut around the 4 identified areas (zone of 1x0.5cm cut on the high corner of each area sampling)
• Subjects who demonstrate understanding of the study and willingness to participate as evidenced by voluntary written informed consent and have received a signed and dated copy of the informed consent form.
• Subject affiliated to a social security or insurance system;

Sponsors & Collaborators

• L'Oreal: lead

Study Sites (1)

Interteck

Paris, 75013, France

Location

MeSH Terms

Conditions

Dandruff

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Scalp Dermatoses

Central Study Contacts

Sayeh POURHAMIDI, pHD

CONTACT

0660992467; sayeh.pourhamidi@rd.loreal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: To evaluate the impact of an anti-dandruff shampoo compared to vehicle (placebo) on scalp microflora composition after 4 weeks of treatment and 4 weeks of relapse, on healthy volunteers with moderate to severe dandruff status

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 18, 2022
• Study Start: October 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 18, 2022

Record last verified: 2022-08

Locations

FR (1)