A Scalp Lotion Toimprove Sensitive Scalp Syndrome | NCT05630027

Studies
A Scalp Lotion Toimprove Sensitive Scalp Syndrome

NCT05630027

Sponsor

Cosmetique Active International

Status

Completed

Last Update Posted

Nov 29, 2022Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Alopecia
Sensitive Skin

Interventions

Piroctone Olamine (PO), 2,4 Diaminopyrimidine oxide (2.4 DA) and Vichy mineralizing water

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2019Actual

Primary Completion Date

Jun 30, 2020Actual

Completion Date

Jun 30, 2020Actual

First Submitted Date

Nov 18, 2022

First Submission Date that Met QC Criteria

Nov 18, 2022

First Posted Date

Nov 29, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2022

Last Update Posted Date

Nov 29, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Overall, 100 Caucasian subjects participated in this 6-weeks lasting study, AC5+ was applied daily. All subjects had clinically confirmed mild to moderate alopecia and self-declared sensitive scalp. Instrumental assessments included Trans Epidermal Water Loss (TEWL), inflammation markers, clinical assessments included the severity of erythema, inflammation and greasiness. Subjective/Self assessments comprised the intensity of the scalp itch/pruritus and the evaluation of their head hair status (volume, abundance, strength). Same assessments were provided by the investigators.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Piroctone Olamine (PO), 2,4 Diaminopyrimidine oxide (2.4 DA) and Vichy mineralizing water	Other	observational, prospective study

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
erythema	on a scale from o=none to 5=severe	Baseline
erythema	on a scale from o=none to 5=severe	Day 21
inflammation	on a scale from o=none to 5=severe	Baseline
inflammation	on a scale from o=none to 5=severe	Day 21
greasiness	on a scale from o=none to 5=severe	Baseline
greasiness	on a scale from o=none to 5=severe	Day 21
Global soothing score	sum of the symptoms with a score up to 15	Baseline
Global soothing score	sum of the symptoms with a score up to 15	Day 21

Secondary Outcomes

Measure	Description	Time Frame
pruritus	on a scale from o=none to 5=severe	Baseline
pruritus	on a scale from o=none to 5=severe	Day 21

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>18 years
mild alopecia:
female: Ludwig type 1
male: Hamilton III to IV type

Exclusion Criteria:

Moderate or severe alopecia
Dandruff

Accepts Healthy Volunteers

Not provided

Sex

Not provided

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Adult subjects with mild alopecia and no dandruff

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philippe Massiot	L'OREAL Research and Innovation, Saint-Ouen, France	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
L'OREAL Research and Innovation		Saint-Ouen			France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000505	Alopecia

Ancestor Terms

ID	Term
D007039	Hypotrichosis
D006201	Hair Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C052599	piroctone olamine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided