A Scalp Lotion Toimprove Sensitive Scalp Syndrome

November 18, 2022 updated by: Cosmetique Active International

Soothing and Anti-hair Loss Activity of a Scalp Lotion Containing Piroctone Olamine, 2,4 Diaminopyrimidine Oxide and Vichy Mineralizing Water

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Ouen, France
        • L'OREAL Research and Innovation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult subjects with mild alopecia and no dandruff

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Moderate or severe alopecia
  • Dandruff

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pruritus
Time Frame: Baseline
on a scale from o=none to 5=severe
Baseline
pruritus
Time Frame: Day 21
on a scale from o=none to 5=severe
Day 21
burning
Time Frame: Baseline
on a scale from o=none to 5=severe
Baseline
burning
Time Frame: Day 21
on a scale from o=none to 5=severe
Day 21
stinging
Time Frame: Baseline
on a scale from o=none to 5=severe
Baseline
stinging
Time Frame: Day 21
on a scale from o=none to 5=severe
Day 21
scratching
Time Frame: Baseline
on a scale from o=none to 5=severe
Baseline
scratching
Time Frame: Day 21
on a scale from o=none to 5=severe
Day 21
hair quality
Time Frame: Baseline
on a scale from o=none to 5=severe
Baseline
hair quality
Time Frame: Day 21
on a scale from o=none to 5=severe
Day 21
Transepidermal water loss
Time Frame: Baseline
instrumental measurements
Baseline
Transepidermal water loss
Time Frame: Day 21
instrumental measurements
Day 21
Inflammation markers
Time Frame: Baseline
skin swabs analysis
Baseline
Inflammation markers
Time Frame: Day 21
skin swabs analysis skin swabs analysis
Day 21
squalene
Time Frame: Baseline
skin swabs analysis skin swabs analysis
Baseline
squalene
Time Frame: Day 21
skin swabs analysis skin swabs analysis
Day 21
Squalene monohydroperoxide
Time Frame: Baseline
skin swabs analysis
Baseline
Squalene monohydroperoxide
Time Frame: Day 21
skin swabs analysis
Day 21

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cosmetique Active International

Investigators

  • Study Director: Philippe Massiot, L'OREAL Research and Innovation, Saint-Ouen, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2019

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

November 18, 2022

First Submitted That Met QC Criteria

November 18, 2022

First Posted (Actual)

November 29, 2022

Study Record Updates

Last Update Posted (Actual)

November 29, 2022

Last Update Submitted That Met QC Criteria

November 18, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC5+

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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