Skin DiseasesNCT05767333
Evaluation of Cicaplast in Subjects With Skin Irritation
An observational study of Skin Diseases, run by Cosmetique Active International at 4 sites in 4 countries.
Trial summary
The aim of this open, before/after, multicentric study is to assess the effect and tolerance of Cicaplast Baume B5 in patients having a skin irritation (irritative and cracked dermatitis, dry eczematids, rubbing irritation, ...) under dermatological control. Read more about this study
- Who is it for?
- Ages 3 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Diseases
- How many people
- 109 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 11 Oct 2021to 6 Jun 2022
- 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 3 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: adults, teens and children meeting the inclusion and exclusion criteria and willing to adhere to the protocol and study procedures
Who may be able to join
- subjects presenting the following skin irritations (at least 3 to 5 per irritation): irritative and cracked dermatitis, dry eczematids/dry patches, rubbing irritation in specific location (ex: thumb frictions, lichenifications), ...
- localization of irritation lesions: face, limbs, trunk, feet, fold, hands, ...
- subjects having a feeling of discomfort at the site of the lesion.
Who cannot join
- cutaneous pathology on the studied zone (other than the required irritations)
- use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous acceptability of the study product (according to the investigator's appreciation);
- subject with healing disorder (keloid, hypertrophic)
- subject with Type 1 diabetic
- subject under chemotherapy and radiotherapy
- subject with a skin disease on evaluation site: psoriasis and atopic dermatitis active lesions and hand dermatitis
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Evaluation of Cicaplast in Subjects With Skin Irritation for 21 Days
The aim of this open, before/after, multicentric study is to assess the effect and tolerance of Cicaplast Baume B5 in patients having a skin irritation (irritative and cracked dermatitis, dry eczematids, rubbing irritation, ...) under dermatological control. Patients are asked to apply the product at least twice a day until complete recovery (maximum 21 days).
Read the detailed description
Dermscan has implemented a quality management system which has been certified by the International Standards Organization (ISO 9001: 2015). This quality assurance system includes appropriate Good Clinical Practices (GCP) and regulation requirements. The proofreader is not involved in the audited study. A certificate of quality inspection signed by the person who checked the report is enclosed in each study.
Statistical method
Regarding the descriptive analysis, the quantitative data is summarized using the following statistics by time point:
- Number of values
- Mean
- Median
- Standard deviation (SD)
- Minimum value
- Maximum value.
Are summarized in frequency (N) and percentage (%) by time point:
- the Investigator's Global Assessment (IGA) score assessed by the investigator using a 6-point scale
- the soothing effect assessed by the subject using a 4-point scale for the parameters pain and pruritus
- each global tolerance score assessed by the investigator and by the subject using a 4-point scale.
The score of anti-irritating effect (SCOre de REparation de l'EPIderme= SCOREPI) is summarized using statistics for quantitative variables at each time point.
The local signs of irritated area assessed using a 4-point scale (erythema, desquamation, pigmentation, cracks, oedema) are summarized in frequency (N) and percentage (%) and by time point and by parameter.
- Conditions
- Skin Diseases
- Keywords
- skin irritation, irritative dermatitis, superficial burn
- Medical subject headings
- Skin Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of the effect on the recovery of irritated skin lesions
the investigator evaluates the improvement of the tested product using the IGA score on a 6-point scale (from -1: aggravation to 4: complete recovery)
Measured: from baseline to Day21
Secondary outcomes (8)
evaluation of the local signs of irritated area
the investigator assesses the local signs (erythema, desquamation, pigmentation, cracks, oedema) using a 4-point scale (from absent to severe)
Measured: from baseline to Day21
evaluation of the anti-irritating effect
the investigator evaluates the lesions using SCOREPI tool which takes into account the following parameters: total surface of the skin lesions, erythema, desquamation, and cracks.
Measured: from baseline to Day21
evaluation of the skin sensitivity
the patient evaluates the sensitivity of irritated areas using a 4-point scale for pain and pruritus ((from 0= absent to 3= severe)
Measured: from baseline to Day21
evaluation of the global tolerance by the investigator
the investigator evaluates the global tolerance using a 4-point scale (from 0=null to 3= excellent)
Measured: from baseline to Day21
evaluation of the global tolerance by the patient
the patient evaluates the global tolerance using a 4-point scale (from 0=null to 3= excellent)
Measured: from baseline to Day21
evaluation of post-recovery marks
the investigator assesses post-recovery marks score concerning type (redness, hyperpigmentation, hypopigmentation) and severity using a 4-point scale (from 1= almost absent to 4= severe) of an irritated area
Measured: Day21
evaluation of the global effect by the investigator
the investigator evaluates the global effect using a 5-point scale (from -1= worsening to 3= excellent)
Measured: Day21
evaluation of the global effect by the patient
the patient evaluates the global effect using a 5-point scale (from -1= worsening to 3= excellent)
Measured: Day21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start11 Oct 2021
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin DiseasesStudies 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
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cosmetique Active International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Caroline Le Floc'h, Study director, Cosmetique Active International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05767333
- Sponsor's protocol ID
- LRP21005-CICAPLAST BAUME B5
- Status last verified
- Mar 2023
- First submitted
- 2 Mar 2023
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cicaplast in Subjects With Skin Irritation for 21 Days
- ClinicalTrials.gov ID
- NCT05767333
- Acronym / sponsor ID
- LRP21005-CICAPLAST BAUME B5
- Conditions
- Skin Diseases
- Keywords
- skin irritation, irritative dermatitis, superficial burn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Cosmetique Active InternationalIndustry (pharma, biotech, devices)
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 14 Mar 2023 (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.
The aim of this open, before/after, multicentric study is to assess the effect and tolerance of Cicaplast Baume B5 in patients having a skin irritation (irritative and cracked dermatitis, dry eczematids, rubbing irritation, ...) under dermatological control. Patients are asked to apply the product at least twice a day until complete recovery (maximum 21 days).
Detailed description
Dermscan has implemented a quality management system which has been certified by the International Standards Organization (ISO 9001: 2015). This quality assurance system includes appropriate Good Clinical Practices (GCP) and regulation requirements. The proofreader is not involved in the audited study. A certificate of quality inspection signed by the person who checked the report is enclosed in each study.
Statistical method
Regarding the descriptive analysis, the quantitative data is summarized using the following statistics by time point:
- Number of values
- Mean
- Median
- Standard deviation (SD)
- Minimum value
- Maximum value.
Are summarized in frequency (N) and percentage (%) by time point:
- the Investigator's Global Assessment (IGA) score assessed by the investigator using a 6-point scale
- the soothing effect assessed by the subject using a 4-point scale for the parameters pain and pruritus
- each global tolerance score assessed by the investigator and by the subject using a 4-point scale.
The score of anti-irritating effect (SCOre de REparation de l'EPIderme= SCOREPI) is summarized using statistics for quantitative variables at each time point.
The local signs of irritated area assessed using a 4-point scale (erythema, desquamation, pigmentation, cracks, oedema) are summarized in frequency (N) and percentage (%) and by time point and by parameter.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- adults, teens and children meeting the inclusion and exclusion criteria and willing to adhere to the protocol and study procedures
Key inclusion criteria (3 listed)
- subjects presenting the following skin irritations (at least 3 to 5 per irritation): irritative and cracked dermatitis, dry eczematids/dry patches, rubbing irritation in specific location (ex: thumb frictions, lichenifications), ...
- localization of irritation lesions: face, limbs, trunk, feet, fold, hands, ...
- subjects having a feeling of discomfort at the site of the lesion.
Key exclusion criteria (6 listed)
- cutaneous pathology on the studied zone (other than the required irritations)
- use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the cutaneous acceptability of the study product (according to the investigator's appreciation);
- subject with healing disorder (keloid, hypertrophic)
- subject with Type 1 diabetic
- subject under chemotherapy and radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluation of the effect on the recovery of irritated skin lesions
Time frame: from baseline to Day21
the investigator evaluates the improvement of the tested product using the IGA score on a 6-point scale (from -1: aggravation to 4: complete recovery)
8 secondary outcomes
evaluation of the local signs of irritated area
Time frame: from baseline to Day21
evaluation of the anti-irritating effect
Time frame: from baseline to Day21
evaluation of the skin sensitivity
Time frame: from baseline to Day21
evaluation of the global tolerance by the investigator
Time frame: from baseline to Day21
evaluation of the global tolerance by the patient
Time frame: from baseline to Day21
evaluation of post-recovery marks
Time frame: Day21
evaluation of the global effect by the investigator
Time frame: Day21
evaluation of the global effect by the patient
Time frame: Day21
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 14 Mar 2023.
Related trials for Skin Diseases
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
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.
Caroline Le Floc'h study director
Cosmetique Active International
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Diseases, run by Cosmetique Active International at 4 sites in 4 countries.
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 3 inclusion and 6 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 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, China, Mauritius, Poland. 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?
evaluation of the effect on the recovery of irritated skin lesions (time frame: from baseline to Day21). 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 14 Mar 2023.