Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05006300 |
| Other study ID # |
TOPIA-2021.03 |
| Secondary ID |
2021-A00613-38 |
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2021 |
| Est. completion date |
March 2022 |
Study information
| Verified date |
October 2022 |
| Source |
SVR Group |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of this study is to evaluate the efficacy and tolerability of a new SVR care
product and to evaluate the reduction of the topical corticosteroids' consumption with this
emollient care.
Atopic dermatitis is a vicious circle that must be broken, but certain aggravating factors
are added to this circle. There is a lot of talk about pollution but, more recently, studies
have been carried out on the worsening role of dust mites on atopic skin.
The SVR product is therefore based on it:
TOPIALYSE Baume Barrière is a care product that is lipid-replenishing, repairing and
protective: a triple reinforced action for 48 hours: anti-scratching, anti-irritation, and
anti-external aggression.
Description:
1. RATIONALE
The mainstay of treatment for Atopic dermatitis (AD) is use of emollient and topical
medications. Topical corticosteroids are the gold standard of anti-inflammatory therapy in AD
especially AD flare-ups, in order to reduce inflammation and pruritus. Their long-term use is
associated with the risk of local and systemic adverse effects.
The purpose of this study is to evaluate the efficacy and tolerability of TOPIALYSE Baume
Barrière and to evaluate the reduction of the topical corticosteroids' consumption with this
emollient care.
2 STUDY OBJECTIVES
2.1 PRIMARY OBJECTIVE: The main objective of this study is to evaluate the efficacy of the
cosmetic product SVR TOPIALYSE Baume Barrière on the reduction of topical corticosteroid
consumption in children from 3 months to 17 years old presenting mild to moderate atopic
dermatitis (5 < SCORAD < 40), after 28 days of use.
2.2 SECONDARY OBJECTIVE: 2.2.1. To evaluate the efficacy of the study product after 28 and 56
days of use on children of 3 months to 17 years with mild to moderate atopic dermatitis by
the following criteria:
1. Number of flare-up
2. SCORAD
3. Amount of topical corticosteroid consumption
4. Mean PO-SCORAD
5. Quality of life
6. Skin condition and functional skin signs
2.2.2 Evaluate the tolerance of the study product after 28 and 56 days of use on
children 3 months to 17 years old with mild to moderate atopic dermatitis
2.2.3. To evaluate the persistent effect of the cosmetic product SVR TOPIALYSE Barrier
Balm after 24 and 48 hours of stopping use on children from 3 months to 17 years old
with mild to moderate atopic dermatitis
3 STUDY METHODOLOGY This is a multicentric, randomized and open-label study. It is an
interventional study with minimal risks (Category 2).
3.1 EVALUATION CRITERIA (see outcomes part)
3.2 EVALUATION METHODS
3.2.1 Topical corticosteroid consumption Consumption of class 2 or 3 topical
corticosteroids will be assessed throughout the study by the number of days of use and
the weight of the topical corticosteroid tube per month.
3.2.2 SCORAD At D -37, D -7, D0, D28 and D56, the dermatologist calculates the objective
SCORAD over the entire body.
A. First, the investigator assesses the distribution of atopic dermatitis by calculating
the extent. For each zone, the investigator evaluates the proportion of the zone
considered affected by atopic dermatitis compared to the suggested maximum score.
B. Second, the investigator scores the intensity of the following parameters: erythema,
oedema/papules, oozing/crust, excoriation, lichenification and xerosis
C. Finally, the investigator questions the subjects about their subjective symptoms:
pruritus abd insomnia
The total score of the objective SCORAD is obtained according to the following formula:
SCORAD = A/5 + 7 B/2 + C
3.2.3 Skin condition assessment 3.2.4 IDQOL questionnaire 3.2.5 Local tolerance
assessment 3.2.6 Cutaneous functional signs assessment 3.2.7 Study product questionnaire
3.2.8 Standardized photographs
4 SELECTION OF STUDY POPULATION Sixty-two children (62) will be enrolled in the study.
The subjects will be recruited via the Necker Volunteer Database or from those who
spontaneously come to the Necker Children's Hospital or the Pr. Tennstedt' medical
office or if needed, via press advertising after approval by the Ethics Committee.
5. DURATION OF TREATMENT, DOSING AND ADMINISTRATION 5.1 Duration of treatment Depending
on the group, the tested products will be applied for fifty-six days either
consecutively (Group 1) or with one application every two days (Group 2).
6 INVESTIGATIONAL PLAN 6.1 STUDY DESIGN This is a multicentric, randomized and
open-label study. It is an interventional study with minimal risks (Category 2).
The study will be performed in 62 children with mild to moderate atopic dermatitis. The
screening of the subjects will be performed at the Necker-Enfants malades hospital and
at the Pr Tennstedt medical office within three weeks (D -58) prior to the enrollment
visit at D -37 and to allow verification of the subject compatibility with the inclusion
and exclusion criteria.
6.1.1 Study location The study will be performed in two Investigation centers, the
Necker-Enfant malades hospital, authorized by the Regional Agency of Health (ARS) to
perform biomedical research and the Pr. Tennstedt medical office.
6.1.2 Study duration The study participation for each subject will last up to 3 months
(21 days for screening and 95 days of clinical participation).
6.2 STUDY PROCEDURES
6.2.1 Screening visit (visit 1): D -58 to D -37 The screening visit will be performed
within three weeks of the day before D -37. The following procedures may be carried on
several days if needed.
- Subject information and presentation of the informed consent form,
- Inclusion/ exclusion criteria checking. 6.2.2 Enrollment/ inclusion visit (Visit
2), phase 1: D -37
The subject will have to come to the investigator site for:
- Inclusion/ exclusion criteria checking,
- Informed consent signature,
- Medical history and concomitant therapies,
- Physical examination: general aspects, height, weight,
- Vital signs: sitting systolic and diastolic blood pressure (mm-Hg) and pulse rate
(beats per minute) after a 5-minute rest,
- Clinical scoring with the SCORAD (Scoring Atopic Dermatitis),
- Recording information on the topical corticosteroid usually used in the atopic
dermatitis flare-up on the source file and the e-CRF,
- Weighing and recording the weight of the topical corticosteroid tube on the source
folder and the e-CRF,
- Distribution of patient diary for adverse events and number of relapses,
- Distribution of patient cards with study information,
- Downloading of the PO-SCORAD (Patient-Oriented Scoring Atopic Dermatitis) mobile
application by the subjects' parents and explanation of the instructions and dates
for filling in the booklet,
- Evaluation of the quality of life with IDQOL (Infant's Dermatitis Quality of Life
index) questionnaire,
- Standardized photographs if desired and authorized,
- Appointment for the next visits on D-7, D0, D28, D56, D57 and D58 and record them
on the patient diary and patient study card.
- Provision of the patient diary.
Between this visit and the next:
- Use of the usual emollient,
- Application of the usual topical corticosteroid in case of atopic dermatitis
flare-up,
- Weekly filling of the PO-SCORAD,
- Filling of the patient diary every day.
6.2.3 Follow-up visit 1 (visit 3), end of phase 1: D -7
- Checking the patient diary,
- Verification of adverse events,
- Verification of concomitant medication modifications,
- Weighing and recording the weight of the topical corticosteroid tube on the source
folder and the e-CRF,
- Completion of the source files and the e-CRF,
- Subject is randomized according to a randomization list (attributed in
chronological order),
- Dermatological examination by local 5-point tolerance scale by the investigator,
- SCORAD clinical scoring,
- Evaluation of the quality of life with IDQOL (Infant's Dermatitis Quality of Life
Index) questionnaire,
- Standardized photographs if desired and authorized,
- Reminder of the next D0 appointment.
6.2.4 Wash-out period: D-7 to D0 After this visit, the patients have to stop using the
usual emollient and the usual topical corticosteroid, weekly filling of the PO-SCORAD
application and filling out the patient diary every day.
6.2.5 Follow up visit 2 (visit 4), starting phase 2: D0
- Checking the patient diary,
- Verification of adverse events,
- Verification of concomitant medication modifications,
- Completion of the source files and the e-CRF,
- SCORAD clinical scoring,
- Dermatological examination by local 5-point tolerance scale by the investigator or
co-investigator,
- Scoring of skin condition by the investigator or co-investigator,
- Assessment questionnaire of skin condition by the subject' parent,
- Assessment questionnaire of tolerance and signs of skin intolerance by the subject'
parent,
- ID-QOL questionnaire,
- Standardized photographs if desired and authorized
- Product distribution,
- Weighing of study products and topical corticosteroid recording in the source
folder and e-CRF,
- First pat of the product,
- Reminder of the next T28 appointment.
Between this visit and the next:
- Use of the TOPIALYSE emollient once a day or once every 2 days depending on
randomization,
- Application of the usual topical corticosteroid in case of atopic dermatitis
flare-up,
- Weekly filling of the PO-SCORAD,
- Filling of the patient diary every day.
6.2.6 Follow-up visit 3 (Visit 5), phase 2: D28
- Checking the patient diary,
- Verification of adverse events,
- Verification of concomitant medication modifications,
- Completion of the source files and the e-CRF,
- SCORAD clinical scoring,
- Dermatological examination by local 5-point tolerance scale by the investigator or
co-investigator,
- Scoring of skin condition by the investigator or co-investigator,
- Assessment questionnaire of skin condition by the subject' parent,
- Assessment questionnaire of tolerance and signs of skin intolerance by the subject'
parent,
- ID-QOL questionnaire,
- Standardized photographs if desired and authorized,
- Weighing of study products and topical corticosteroid recording in the source
folder and e-CRF,
- Reminder of the next T56 appointment.
Between this visit and the next:
- Use of the TOPIALYSE emollient once a day or once every 2 days depending on
randomization,
- Application of the usual topical corticosteroid in case of atopic dermatitis
flare-up,
- Weekly filling of the PO-SCORAD,
- Filling of the patient diary every day.
6.2.7 Follow-up visit 4 (visit 6), phase 2: D56
- Checking the patient diary,
- Verification of adverse events,
- Verification of concomitant medication modifications,
- Completion of the source files and the e-CRF,
- SCORAD clinical scoring,
- Dermatological examination by local 5-point tolerance scale by the investigator or
co-investigator,
- Scoring of skin condition by the investigator or co-investigator,
- Assessment questionnaire of skin conditions by the subject' parent,
- Assessment questionnaire of tolerance and signs of skin intolerance by the subject'
parent,
- ID-QOL questionnaire,
- Subjective assessment questionnaire on the study product by the subject' parent,
- Standardized photographs if desired and authorized,
- Weighing of study products and topical corticosteroid recording in the source
folder and e-CRF,
- Collection of the patient diary,
- Collection of study products.
After this visit, the patients have to stop using the TOPIALYSE Baume Barrière emollient
and the topical corticosteroid.
6.2.8 Follow-up visit 5, phase 2: D57 - Assessment questionnaire for skin condition,
- Questionnaire for assessment of tolerance and signs of skin intolerance,
- Filling the PO-SCORAD. This part will only be done by the subject' parent and send
to the study center.
6.2.9 Follow-up visit 6/ End of Study: D58 - Assessment questionnaire for skin
condition,
- Questionnaire for assessment of tolerance and signs of skin intolerance,
- Filling the PO-SCORAD,
- Delivery of documents to the investigator centre. This part will only be done by the
subject' parent and send to the study center.
7 STATISTICAL METHODS 7.1 BASELINE CHARACTERISTICS Continuous demographic variables
(e.g. age, weight, and height) will be summarized, using mean, standard deviation,
minimum, maximum and number of available observations.
Qualitative demographic characteristics will be summarized by counts and percent. Other
subject characteristics (anomalies in physical examination, prior medication, inclusion
/ exclusion checklist) will be listed only.
7.2 STATISTICAL ANALYSES Descriptive statistics (N, mean, standard error, min, max,)
will be calculated by test product for each parameter.
Prior to any statistical analysis, the normality of each variable will be tested using
the Shapiro Wilks test of normality.
Statistical Tests:
For each normal variable, comparisons will be performed using a t-test for paired data.
For each non normal variable, comparison will be performed using a Wilcoxon rank sum
test.
7.3 NUMBER OF SUBJECTS CALCULATION In the treatment of atopic dermatitis, the use of a
simple emollient makes it possible to reduce by about 10% the amount of topical
corticosteroid used [33]. In the present study, it is expected that TOPIALYSE Baume
Barrière applied 1 application/day will reduce the consumption of topical corticosteroid
by at least 35% after 28 days of application based on the results of the study of
GIORDANO-LABADIE et al, 2006. Calculation of the number of patients by the Arcsinus
method shows that 31 patients would allow to detect a significant difference between
TOPIALYSE Baume Barrière applied 1 application/day and the reference value 10% with a
power of 95% at risk α =0.05 (bilateral test). It is also expected that TOPIALYSE Baume
Barrière applied 1 application/2 days will lead to a comparable decrease, therefore 31
patients will also be included in this group.
