Evaluation of the Efficacy of SeS2 Shampoo on Subjects Having Dandruff
Primary Purpose
Dandruff
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
dermatological product
Sponsored by
About this trial
This is an interventional treatment trial for Dandruff focused on measuring Squamous, Malassezia, bacteria
Eligibility Criteria
Inclusion Criteria:
- 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
- Subjects having at inclusion visit Day 0:
- 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 having on inclusion Day 0, 2 areas with dandruff (score > 2.5) (one of 1x1cm2, the other of 2 x 2cm2) and 2 areas without dandruff (score < 1) (one of 1x1cm2, the other of 2 x 2cm2) in the vertex if possible
- 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;
- Subjects willing to comply to the study requirements;
- Subjects who are willing not to take part in another clinical study in another investigating centre;
- Subjects who agree to give accurate personal information;
- Subjects who are able to attend all study visits. * The effective contraceptive methods: sexually active females of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide,intravaginal device, intrauterine device (IUD), condom with spermicide
Exclusion Criteria:
Inclusion Criteria
- 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;
- Subjects having at inclusion visit Day 0:
- 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 having on inclusion Day 0, 2 areas with dandruff (score > 2.5) (one of 1x1cm2, the other of 2 x 2cm2) and 2 areas without dandruff (score < 1) (one of 1x1cm2, the other of 2 x 2cm2) in the vertex if possible
- 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;
- Subjects willing to comply to the study requirements;
- Subjects who are willing not to take part in another clinical study in another investigating centre;
- Subjects who agree to give accurate personal information;
- Subjects who are able to attend all study visits. * The effective contraceptive methods: sexually active females of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide,intravaginal device, intrauterine device (IUD), condom with spermicide
Exclusion Criteria
- Subjects with any systemic disorder or skin disease that would, in the investigator's judgment, significantly affect the interpretation of the study results (e.g. seborrheic dermatitis which shows the syndrome of invasion plaque and/or pityriasis amiantacea, atopic dermatitis, eczema or psoriasis);
- Subjects with cutaneous affection of the scalp (psoriasis, atopic dermatitis, seborrheic dermatitis which shows the syndrome of invasion plaque and/or pityriasis amiantacea, …);
- Female subjects who are known to be pregnant or who are intending to become pregnant over the duration of the study;
- Female subjects who are currently breast-feeding or have been breast-feeding in the 6 months prior to the start of the study;
- Male subjects with alopecia grade ≥ V according to Hamilton-Norwood patterns, female subjects with alopecia grade I, II or III according to Ludwig patterns;
- Subjects with frizzy hair influencing the scoring of dandruff;
- Subjects with significant white hair influencing the scoring of dandruff;
- Subjects who have skin marks on the scalp that could interfere with the assessments (e.g. pigmentation, tattoo, scarring etc.);
- Subjects who have used products for the scalp (dyeing, bleaching, permanent waving and straightening …) within the three weeks prior to the study;
- Subjects who have used anti-dandruff treatment (per os or topical) during the last three weeks before the start of the study;
- Subjects who have used cosmetic anti-hairloss treatment (per os or topical) during the last three months before the start of the study, or/and subject who has used medical anti-hair loss treatment (per os or topical, ex: Minoxidil, finasteride, etc…) during the last six months before the start of the study;
- Subjects with personal history of allergy and/or particular reactivity to antidandruff products, and/or to cosmetic products containing tensioactive agents (soaps, shower gel, conditioner …), and/or to latex;
- Subjects who have taken any systemic drug containing corticoids, or anti-fungal, or antibiotics, or any prolonged use of topical drug containing corticoids, or anti-fungal, or antibiotics, or any prolonged use of non-steroidal anti-inflammatory, or anti-histaminic within one month prior to the study;
- Subjects who have taken retinoic acid since less than three months prior to the study;
- Subjects receiving other medication which, in the opinion of the investigator, will affect either the scientific validity of the study or the subject's wellbeing.
- Subjects with a history of medical/surgical events (or surgical events planned) which, in the opinion of the investigator, will affect either the scientific validity of the study or the subject's wellbeing;
- Immunosuppressed subject;
- Subjects with medical history of skin cancer;
- Subjects who have started, stopped or changed his/her hormonal treatment (including contraceptive pill) in the previous one month prior to the study;
- Subjects practicing regularly water sports and/or having regularly sauna sessions;
- Subjects exposed to the sun or UV rays in an excessive way during the last month prior to the study (according to the investigator);
- Subjects deprived of liberty by adjunction or by official decision;
- Subjects who are participating or who has participated to a clinical study for which the exclusion period is not finished;
- Subjects unable to be contacted by phone;
- Subjects belonging to the staff of the investigating centre
Sites / Locations
- Interteck
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Selenium disulfide shampoo
placebo shampoo
Arm Description
Outcomes
Primary Outcome Measures
Analysis of microflora from swabs for fungi quantification
malassezia qPCR
Analysis of microflora from swabs for bacteria quantification
Cutibacterium qPCR
Analysis of microflora from swabs for bacteria diversity
sequencing 16S
Analysis of microflora from swabs for fungi diversity
sequencing ITS
Secondary Outcome Measures
Grading of Dandruff severity
Dandruff severity 0-5 ordinal scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05506592
Brief Title
Evaluation of the Efficacy of SeS2 Shampoo on Subjects Having Dandruff
Official Title
Evaluation of the Efficacy of an Anti Dandruff Shampoo Against Placebo on Dandruff and Scalp Microflora Composition After 4 Weeks of Treatment and 4 Weeks of Relapse
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2022 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
L'Oreal
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dandruff
Keywords
Squamous, Malassezia, bacteria
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Selenium disulfide shampoo
Arm Type
Active Comparator
Arm Title
placebo shampoo
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
dermatological product
Intervention Description
cosmetic shampoo
Primary Outcome Measure Information:
Title
Analysis of microflora from swabs for fungi quantification
Description
malassezia qPCR
Time Frame
1 month
Title
Analysis of microflora from swabs for bacteria quantification
Description
Cutibacterium qPCR
Time Frame
1 month
Title
Analysis of microflora from swabs for bacteria diversity
Description
sequencing 16S
Time Frame
1 month
Title
Analysis of microflora from swabs for fungi diversity
Description
sequencing ITS
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Grading of Dandruff severity
Description
Dandruff severity 0-5 ordinal scale
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Clinical assessment of oily aspect of the scalp
Description
oily aspect of the scalp 1-5 ordinal scale
Time Frame
1 month
Title
Clinical assessment of erythema
Description
erythema 0-5 ordinal scale
Time Frame
1 month
Title
Self-perception of efficacy: dandruff
Description
Self-perception of dandruff 5-point-scale
Time Frame
1 month
Title
Self-perception of efficacy greasy aspect
Description
Self-perception of greasy 10-point-scale
Time Frame
1 month
Title
Self-perception of efficacy global efficacy
Description
Self-perception of global efficacy 5-point-scale
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Subjects having at inclusion visit Day 0:
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 having on inclusion Day 0, 2 areas with dandruff (score > 2.5) (one of 1x1cm2, the other of 2 x 2cm2) and 2 areas without dandruff (score < 1) (one of 1x1cm2, the other of 2 x 2cm2) in the vertex if possible
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;
Subjects willing to comply to the study requirements;
Subjects who are willing not to take part in another clinical study in another investigating centre;
Subjects who agree to give accurate personal information;
Subjects who are able to attend all study visits. * The effective contraceptive methods: sexually active females of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide,intravaginal device, intrauterine device (IUD), condom with spermicide
Exclusion Criteria:
Inclusion Criteria
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;
Subjects having at inclusion visit Day 0:
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 having on inclusion Day 0, 2 areas with dandruff (score > 2.5) (one of 1x1cm2, the other of 2 x 2cm2) and 2 areas without dandruff (score < 1) (one of 1x1cm2, the other of 2 x 2cm2) in the vertex if possible
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;
Subjects willing to comply to the study requirements;
Subjects who are willing not to take part in another clinical study in another investigating centre;
Subjects who agree to give accurate personal information;
Subjects who are able to attend all study visits. * The effective contraceptive methods: sexually active females of childbearing potential should either be surgically sterile (oophorectomy, hysterectomy or tubal ligation), or should use a medically accepted contraceptive regimen: systemic contraceptive (oral, implant, injection), diaphragm or cervical cap with intravaginal spermicide,intravaginal device, intrauterine device (IUD), condom with spermicide
Exclusion Criteria
Subjects with any systemic disorder or skin disease that would, in the investigator's judgment, significantly affect the interpretation of the study results (e.g. seborrheic dermatitis which shows the syndrome of invasion plaque and/or pityriasis amiantacea, atopic dermatitis, eczema or psoriasis);
Subjects with cutaneous affection of the scalp (psoriasis, atopic dermatitis, seborrheic dermatitis which shows the syndrome of invasion plaque and/or pityriasis amiantacea, …);
Female subjects who are known to be pregnant or who are intending to become pregnant over the duration of the study;
Female subjects who are currently breast-feeding or have been breast-feeding in the 6 months prior to the start of the study;
Male subjects with alopecia grade ≥ V according to Hamilton-Norwood patterns, female subjects with alopecia grade I, II or III according to Ludwig patterns;
Subjects with frizzy hair influencing the scoring of dandruff;
Subjects with significant white hair influencing the scoring of dandruff;
Subjects who have skin marks on the scalp that could interfere with the assessments (e.g. pigmentation, tattoo, scarring etc.);
Subjects who have used products for the scalp (dyeing, bleaching, permanent waving and straightening …) within the three weeks prior to the study;
Subjects who have used anti-dandruff treatment (per os or topical) during the last three weeks before the start of the study;
Subjects who have used cosmetic anti-hairloss treatment (per os or topical) during the last three months before the start of the study, or/and subject who has used medical anti-hair loss treatment (per os or topical, ex: Minoxidil, finasteride, etc…) during the last six months before the start of the study;
Subjects with personal history of allergy and/or particular reactivity to antidandruff products, and/or to cosmetic products containing tensioactive agents (soaps, shower gel, conditioner …), and/or to latex;
Subjects who have taken any systemic drug containing corticoids, or anti-fungal, or antibiotics, or any prolonged use of topical drug containing corticoids, or anti-fungal, or antibiotics, or any prolonged use of non-steroidal anti-inflammatory, or anti-histaminic within one month prior to the study;
Subjects who have taken retinoic acid since less than three months prior to the study;
Subjects receiving other medication which, in the opinion of the investigator, will affect either the scientific validity of the study or the subject's wellbeing.
Subjects with a history of medical/surgical events (or surgical events planned) which, in the opinion of the investigator, will affect either the scientific validity of the study or the subject's wellbeing;
Immunosuppressed subject;
Subjects with medical history of skin cancer;
Subjects who have started, stopped or changed his/her hormonal treatment (including contraceptive pill) in the previous one month prior to the study;
Subjects practicing regularly water sports and/or having regularly sauna sessions;
Subjects exposed to the sun or UV rays in an excessive way during the last month prior to the study (according to the investigator);
Subjects deprived of liberty by adjunction or by official decision;
Subjects who are participating or who has participated to a clinical study for which the exclusion period is not finished;
Subjects unable to be contacted by phone;
Subjects belonging to the staff of the investigating centre
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sayeh POURHAMIDI, pHD
Phone
0660992467
Ext
+33
Email
sayeh.pourhamidi@rd.loreal.com
Facility Information:
Facility Name
Interteck
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BERENGERE GUIDET, pHD
Phone
0153687903
Ext
+33
Email
berengere.guidet@intertek.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Evaluation of the Efficacy of SeS2 Shampoo on Subjects Having Dandruff
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