AlopeciaNCT05630027
A Scalp Lotion Toimprove Sensitive Scalp Syndrome
An observational study of Alopecia and Sensitive Skin, run by Cosmetique Active International at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alopecia, Sensitive Skin
- What is being tested?
- Piroctone Olamine (PO), 2,4 Diaminopyrimidine oxide (2.4 DA) and Vichy mineralizing water
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jan 2019to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
Study population: Adult subjects with mild alopecia and no dandruff
Who may be able to join
- >18 years
- mild alopecia:
- female: Ludwig type 1
- male: Hamilton III to IV type
Who cannot join
- Moderate or severe alopecia
- Dandruff
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Alopecia, Sensitive Skin
- Being tested
- Piroctone Olamine (PO), 2,4 Diaminopyrimidine oxide (2.4 DA) and Vichy mineralizing water
- Keywords
- alopecia, sensitive skin, prurit
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piroctone Olamine (PO), 2,4 Diaminopyrimidine oxide (2.4 DA) and Vichy mineralizing waterOther
observational, prospective study
What is being measured
The primary outcome is the main question the study is designed to answer.
erythema
on a scale from o=none to 5=severe
Measured: Baseline
erythema
on a scale from o=none to 5=severe
Measured: Day 21
inflammation
on a scale from o=none to 5=severe
Measured: Baseline
inflammation
on a scale from o=none to 5=severe
Measured: Day 21
greasiness
on a scale from o=none to 5=severe
Measured: Baseline
greasiness
on a scale from o=none to 5=severe
Measured: Day 21
Global soothing score
sum of the symptoms with a score up to 15
Measured: Baseline
Global soothing score
sum of the symptoms with a score up to 15
Measured: Day 21
Secondary outcomes (18)
pruritus
on a scale from o=none to 5=severe
Measured: Baseline
pruritus
on a scale from o=none to 5=severe
Measured: Day 21
burning
on a scale from o=none to 5=severe
Measured: Baseline
burning
on a scale from o=none to 5=severe
Measured: Day 21
stinging
on a scale from o=none to 5=severe
Measured: Baseline
stinging
on a scale from o=none to 5=severe
Measured: Day 21
scratching
on a scale from o=none to 5=severe
Measured: Baseline
scratching
on a scale from o=none to 5=severe
Measured: Day 21
hair quality
on a scale from o=none to 5=severe
Measured: Baseline
hair quality
on a scale from o=none to 5=severe
Measured: Day 21
Transepidermal water loss
instrumental measurements
Measured: Baseline
Transepidermal water loss
instrumental measurements
Measured: Day 21
Inflammation markers
skin swabs analysis
Measured: Baseline
Inflammation markers
skin swabs analysis skin swabs analysis
Measured: Day 21
squalene
skin swabs analysis skin swabs analysis
Measured: Baseline
squalene
skin swabs analysis skin swabs analysis
Measured: Day 21
Squalene monohydroperoxide
skin swabs analysis
Measured: Baseline
Squalene monohydroperoxide
skin swabs analysis
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start2 Jan 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philippe Massiot, Study director, L'OREAL Research and Innovation, Saint-Ouen, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630027
- Sponsor's protocol ID
- AC5+
- Status last verified
- Nov 2022
- First submitted
- 18 Nov 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soothing and Anti-hair Loss Activity of a Scalp Lotion Containing Piroctone Olamine, 2,4 Diaminopyrimidine Oxide and Vichy Mineralizing Water
- ClinicalTrials.gov ID
- NCT05630027
- Acronym / sponsor ID
- AC5+
- Conditions
- Alopecia, Sensitive Skin
- Keywords
- alopecia, sensitive skin, prurit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Adult subjects with mild alopecia and no dandruff
Key inclusion criteria (4 listed)
- >18 years
- mild alopecia:
- female: Ludwig type 1
- male: Hamilton III to IV type
Key exclusion criteria (2 listed)
- Moderate or severe alopecia
- Dandruff
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Piroctone Olamine (PO), 2,4 Diaminopyrimidine oxide (2.4 DA) and Vichy mineralizing waterobservational, prospective study | Other | – |
Primary outcome
erythema
Time frame: Baseline
on a scale from o=none to 5=severe
erythema
Time frame: Day 21
on a scale from o=none to 5=severe
inflammation
Time frame: Baseline
on a scale from o=none to 5=severe
inflammation
Time frame: Day 21
on a scale from o=none to 5=severe
greasiness
Time frame: Baseline
on a scale from o=none to 5=severe
greasiness
Time frame: Day 21
on a scale from o=none to 5=severe
Global soothing score
Time frame: Baseline
sum of the symptoms with a score up to 15
Global soothing score
Time frame: Day 21
sum of the symptoms with a score up to 15
18 secondary outcomes
pruritus
Time frame: Baseline
pruritus
Time frame: Day 21
burning
Time frame: Baseline
burning
Time frame: Day 21
stinging
Time frame: Baseline
stinging
Time frame: Day 21
scratching
Time frame: Baseline
scratching
Time frame: Day 21
hair quality
Time frame: Baseline
hair quality
Time frame: Day 21
Transepidermal water loss
Time frame: Baseline
Transepidermal water loss
Time frame: Day 21
Inflammation markers
Time frame: Baseline
Inflammation markers
Time frame: Day 21
squalene
Time frame: Baseline
squalene
Time frame: Day 21
Squalene monohydroperoxide
Time frame: Baseline
Squalene monohydroperoxide
Time frame: Day 21
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Individual participant dataSharing planned: No
Related trials for Alopecia
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A Study of Baricitinib (LY3009104) in Children From 6 Years to Less Than 18 Years of Age With Alopecia Areata
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A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of ALD-102 Solution in Subjects With Alopecia Areata
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Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Massiot study director
L'OREAL Research and Innovation, Saint-Ouen, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alopecia and Sensitive Skin, run by Cosmetique Active International at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
erythema (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022; AzTrials last refreshed its copy on 6 Nov 2026.