AcneNCT04472546
Use of the SpiderMass for in Vivo Analysis of the Skin in Five Chronic Inflammatory Dermatosis
A study testing in-vivo mesure, Scotch and Lipid index in people with Acne and Atopic Dermatitis, run by Pierre Fabre Dermo Cosmetique at 1 site in France.
Trial summary
The physiological states of the skin are characterized by a certain homeostasis linked to the balance of the metabolic pathways. When these pathways are deregulated, the proteic, lipidic and metabolic is affected. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne, Atopic Dermatitis, Psoriasis Vulgaris
- What is being tested?
- in-vivo mesure, Scotch and Lipid index
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2019to 2 Feb 2024
- Phase
- Interventional
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
--> INCLUSION CRITERIA
CRITERIA RELATED TO THE POPULATION:
- Male or female subject having signed a written informed consent for his/her participation to the study
- Subject with a phototype II to IV according to the Fitzpatrick scale
- Subject affiliated to a social security system or health insurance, or is a beneficiary
- For woman of childbearing potential use of an effective method of contraception, as assessed by the investigator for at least 4 weeks before inclusion in the study
For acne of the face subgroup and its associated control: Male or female, 18 to 30 years old included
For atopic dermatitis of the upper limb subgroup and its associated control: Male or female, 20 to 50 years old included
For vulgar plaque psoriasis subgroup and its associated control: Male or female, 20 to 55 years old included
For telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: Male or female, 30 to 55 years old included
For seborrheic dermatitis of scalp subgroup and its associated control: Male or female, 20 to 45 years old included
CRITERIA RELATED TO DERMATOSIS:
For subjects of the acne of the face subgroup :
-Subjects with mild to severe acne on the face with a GEA (Global Acne Evaluation) score of 2 to 4 on a rating scale ranging from 0 (no injury) to 5 (very severe)
- Subject presenting on the face, at least one zone:
- Lesional in immediate border of a papule
- Peri-lesional near inflammatory lesions (papule, about 1 cm)
- Subject presenting on the inner side of the forearm a reference zone without lesion
For subjects in the atopic dermatitis subgroup of upper limbs:
- Subject with atopic dermatitis on the upper limbs, mild to moderate with SCORAD (SCORing Atopic Dermatitis) between 15 and 40 included with: •A dryness score ≥ 2 on a scale ranging from 0 (absent) to 3 (severe)
- Subject having at least one inflammatory flare of atopic dermatitis on the upper limbs in the 2 years before the day of inclusion
- Subject presenting on the upper limb (hand excluded) at least one zone: •Lesional defined by the signs of target SCORAD between 3 and 12:
- Erythema from 1 to 3
- Dryness ≥2
- Oedema / papule from 0 to 3
- Lesions oozing or crusting 0
- Excoriation of 0
- Lichenification from 0 to 3 On a scale ranging from 0 (absent) to 3 (severe)
- Peri-lesional near the lesion zone (about 1cm)
- Subject presenting on the inner side of the forearm a reference zone without lesion
For vulgar plaque psoriasis subgroup
- Subject with mild to moderate erythematous-squamous plaque psoriasis whose IGA (Investigator Global Assessment) score is between 2 and 3, on a rating scale ranging from 0 (clear) to 5 (very severe)
- Subject with on the upper limb (hand excluded) or lower limb at least one zone:
- Lesional:
- Without fissure and without crust
- With erythema score ≥ 1 on a scale ranging from 0 (absent) to 3 (severe)
- With desquamation score between 1 (mild) and 2 (moderate) on a scale ranging from 0 (absent) to 3 (severe)
- With an oedema score of 0 (absent) on a scale ranging from 0 (absent) to 3 (severe)
- Peri-lesional:
- Without fissure and without crust
- Near the lesion zone (about 1 cm)
- Subject presenting on the inner side of the forearm a reference zone without lesion
For telangiectasic erythrocouperosis papule of the face (rosacea) subgroup
- Subject with telangiectasic erythrocouperosis and papule of the face mild to moderate with an IGA score between 2 and 3 on a rating scale ranging from 0 (absent) to 4 (severe)
- Subject presenting on the face at least one zone:
- Lesional: immediate border of the papule with a persistent erythema score ≥ 1 on a rating scale ranging from 0 (absent) to 3 (severe)
- Peri-lesional:
- Near inflammatory lesions (papule, about 1 cm)
- Ranging of at least 1 point less in the erythema score compared to the lesion zone
- Subject presenting on the inner side of the forearm a reference zone without lesion
For seborrheic dermatitis of scalp subgroup :
- Subject with mild to moderate seborrheic dermatitis with an IGA score between 2 and 3 on a rating scale ranging from 0 (absent) to 4 (severe)
- Subject presenting on the scalp at least one zone:
- Lesional:
- with erythema score ≥ 1 on a scale of 0 (absent) to 3 (severe)
- with clinically visible scales
- Peri-lesional:Near the lesion zone (about 1 cm)
- Subject presenting on the inner side of the forearm a reference zone without lesion
- NON INCLUSION CRITERIA
CRITERIA RELATED TO THE POPULATION:
- For woman of childbearing potential: pregnant or breastfeeding
- Subject unable to understand the information given including study procedures (for linguistic or psychiatric reasons) and to give his/her consent in writing
- Subject who, in the judgement of the investigator, is not likely to be compliant with study-related constraints and requirements
- Subject who has forfeited his/her freedom by administrative or legal award or is under guardianship
- Subject who is in a position likely to represent a conflict of interest and/or is a family member of any people involved in the conduct of the study (secretary, nurse, technician…) of the investigational site
- Subject who is currently participating, who plans to participate or who has participated in another clinical study liable to interfere with the study assessments according to the investigator's assessment
CRITERIA RELATED TO DERMATOSIS AND CUTANEOUS CONDITION:
- Subject with premature cutaneous aging linked to a genetic disease
- Subject with solar erythema in at least one zone under study
- Subject with a tattoo, scar or other dermatological sign on at least one study zone that may interfere with the study according to the investigator's assessment
- Subject with autoimmune disease
- Subject with any type of complication on at least one study area (excoriation type, primary, viral, fungal or parasitic bacterial infection, etc.) according to the investigator's assessment
Criteria for control subgroups:
- Subject with a dermatosis or any type of lesion on the zone corresponding to the lesional, peri-lesional zone or reference zone of the associated subgroup dermatosis likely to interfere with the study according to the investigator's assessment
Criteria for chronic inflammatory dermatitis:
For subjects of the acne of the face subgroup:
- Subject with another dermatosis (chronic / acute, inflammatory, infectious, immune) on the face that could interfere with the study according to the investigator's assessment
For subjects in the atopic dermatitis subgroup of upper limbs:
- Subject with another dermatosis (chronic / acute, inflammatory, infectious, immune) on the upper limb (s) to the study likely to interfere with the study according to the investigator's assessment
For vulgar plaque psoriasis subgroup
- Subject with an isolated palmo-plantar form of psoriasis
- Subject with an isolated form of cutaneous psoriasis other than in plaque (in gout, pustular, erythrodermic or inverted elbow creases (psoriasis of the mucous membranes))
- Subject with another dermatosis (chronic / acute, inflammatory, infectious, immune) on the upper limb (s) and/or lower limb(s) to the study likely to interfere with the study according to the investigator's assessment
For telangiectasic erythrocouperosis papule of the face (rosacea) subgroup
- Subject with another dermatosis (chronic / acute, inflammatory, infectious, immune) on the face that could interfere with the study according to the investigator's assessment
For seborrheic dermatitis of scalp subgroup :
- Seborrheic dermatitis under medical treatment
- Subject with another dermatosis (chronic / acute, inflammatory, infectious, immune) on the scalp likely to interfere with the study according to the investigator's assessment (in particular contact eczema or alopecia)
CRITERIA RELATED TO TREATMENTS AND PRODUCTS
For all subjects :
- Oral intake of isotretinoin or acitretin (oral vit-A and derivatives) within the 6 months prior to the inclusion visit or the day of the visit
- Local retinoid treatment on at least one study zone, which may interfere with the results of the study according to the investigator's assessment within the month preceding the inclusion visit or the day of the visit
- Phototherapy treatment in at least one study zone within 4 weeks prior to the inclusion visit or the day of the visit
- Topical or oral treatment established or modified during the previous weeks or to be established or modified during the study, which may interfere with the results of the study according to the investigator's assessment ( for example modifying the cutaneous characteristics: treatment inducing pigmentation), keratolysis, ...)
- Anti-inflammatory treatment (steroidal or nonsteroidal) taken daily and repeatedly for more than 5 consecutive days during the week preceding the inclusion visit
- Application of any topical vitamin D-derived treatment on at least one study zone within 3 weeks prior to the inclusion visit or the day of the visit
- Application of dermocorticoid topical or immunomodulatory topical treatments (tacrolimus), antifungals, local antibiotics on at least one study zone in the 3 weeks prior to the inclusion visit or the day of the visit
- Application of water, product or topical treatment on at least one zone under study after the last wash the day before the visit
- Application of water, topical product or make-up on at least one zone the day of the inclusion visit
For seborrheic dermatitis of scalp subgroup and its associated control :
- Use on the scalp of any product that can be active on squamous conditions, rinsed or posed (anti-dandruff, anti-fungal shampoo, vinegar rinse, essential oils ...) within 2 weeks prior to the inclusion visit or the day of the visit
- Any technique to change the color or condition of the hair (coloring, discoloration, permanent, smoothing / straightening, ..) performed within 2 weeks prior to the inclusion visit or the day of the visit
- Washing of the scalp done within 2 days before the inclusion visit or the day of the visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using the SpiderMass(TM) for in Vivo and Real Time Mass Spectrometry Analysis of Subject's Epidermis Suffering From Chronic Inflammatory Dermatosis Compared to Control Groups
The physiological states of the skin are characterized by a certain homeostasis linked to the balance of the metabolic pathways. When these pathways are deregulated, the proteic, lipidic and metabolic is affected. It is thus possible to follow a change in the state of the skin by looking at change in the associated molecular profile.
The PRISM laboratory (INSERM U1192) in Lille has developed an innovative system laser called SpiderMass composed of 4 parts:
Read more
- A laser used for the micro-sampling of material in vivo,
- A transport transfer line of the ablated particles,
- A mass spectrometer that analyzes them in real time and generates the molecular profiles of the epidermis,
- A data analysis procedure.
The SpiderMass(TM) is of great interest for the study of the skin because it allows non-invasive vivo characterization, and therefore without biopsy or sample preparation. In addition, it will complement techniques already used in the research center such as FTIR spectroscopy. Indeed, in acne studies the FTIR allows to obtain only the Fatty Acid Triglycerid ratio while the SpiderMass permits to detail these lipid classes by each observed molecule on the surface of the skin and follow their evolution.
- Conditions
- Acne, Atopic Dermatitis, Psoriasis Vulgaris, Rosacea, Seborrheic Dermatitis, Healthy
- Being tested
- in-vivo mesure, Scotch, Lipid index, Absorbant paper, Hydratation Index
- Keywords
- dermatitis, acne of the face, Atopic Dermatitis of the upper limb, Psoriasis Vulgaris, Rosacea, seborrheic dermatitis, SpiderMass, Lipid Index, Laser, Hydratation index, Transepidermal water loss, Scotch sampling, Absorbant paper
- Medical subject headings
- Acne Vulgaris, Dermatitis, Atopic, Rosacea, Dermatitis, Seborrheic, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-vivo mesureOther
Also called SpiderMass mesure
- for acne of the face subgroup and its associated control : face and inner side of the forearm
- for atopic dermatitis of the upper limb subgroup and its associated control: upper limb (hand excluded) and inner side of the forearm
- for vulgar plaque psoriasis subgroup and its associated control: upper limb (hand excluded) or lower limb and inner side of the forearm
- for telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: face and inner side of the forearm
- for seborrheic dermatitis of scalp subgroup and its associated control: scalp and inner side of the forearm
ScotchOther
- for acne of the face subgroup and its associated control : face and inner side of the forearm
- for atopic dermatitis of the upper limb subgroup and its associated control: upper limb (hand excluded) and inner side of the forearm
- for vulgar plaque psoriasis subgroup and its associated control: upper limb (hand excluded) or lower limb and inner side of the forearm
- for telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: face and inner side of the forearm
- for seborrheic dermatitis of scalp subgroup and its associated control: scalp and inner side of the forearm
Lipid indexOther
- for acne of the face subgroup and its associated control : face
- for seborrheic dermatitis of scalp subgroup and its associated control: scalp
- for telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: face
Absorbant paperOther
- for acne of the face subgroup and its associated control : face
- for seborrheic dermatitis of scalp subgroup and its associated control: scalp
- for telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: forehead
Hydratation IndexOther
-for atopic dermatitis of the upper limb subgroup and its associated control: upper limb (hand excluded)
TransEpidermal Water LossOther
-for atopic dermatitis of the upper limb subgroup and its associated control: upper limb (hand excluded)
| Study group | Role | What they receive |
|---|---|---|
| Control subject group | Other | Divided in 5 subgroups :
* A': associated to acne of the face subgroup
* B' : associated to atopic dermatitis of the upper limb subgroup
* C' : associated to vulgar plaque psoriasis subgroup
* D' : associated to telangiectasic erythrocouperosis papule of the face (rosacea) subgroup
* E' : associated to seborrheic dermatitis of scalp subgroup Receives: Other: in-vivo mesure; Other: Scotch; Other: Lipid index; Other: Absorbant paper; Other: Hydratation Index; Other: TransEpidermal Water Loss |
| Subject group with dermatitis | Other | Divided in 5 subgroups :
* A : acne of the face subgroup
* B : Atopic dermatitis of the upper limb subgroup
* C : Vulgar plaque psoriasis subgroup
* D : Telangiectasic erythrocouperosis papule of the face (rosacea) subgroup
* E : Seborrheic dermatitis of scalp subgroup Receives: Other: in-vivo mesure; Other: Scotch; Other: Lipid index; Other: Absorbant paper; Other: Hydratation Index; Other: TransEpidermal Water Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signals and molecular profiles (including lipid) of the epidermis
Defined by characteristic peak mass intensities - SpiderMass
Measured: baseline
Molecular profiles (including lipid) of the epidermis according to sampling method and the measurements of the signals obtained method
- sampling method - absorbant paper, in vivo and / or by scotch
- measurements of the signals obtained -in vivo or FTIR
Measured: baseline
Cutaneous hydratation for atopic dermatitis subgroup and its associated control
By hydratation index - Corneometer
Measured: baseline
State of the cutaneous barrier for atopic dermatitis and corresponding control volunteers
Rate of the Trans Epithelial Water Loss (TEWL) by arbitrary units with an Aquaflux system (Biox Systems Ltd, London. UK)
Measured: baseline
Global lipid quantity measured on face acnea, scalp seborrheic dermatitis, face rosacea (papulotelangiectasic stage of erythrocouperosis) and corresponding control volunteers
Global sebum level measurement expressed in arbitrary index with a Sebumeter SM815 system (Courage+Khazaka electronic GmbH, Köln. Germany)
Measured: baseline
Skin state evaluation on the lesional and perilesional areas
Illustrative descriptions of the skin state with photographs, taken by an iPhone 6S (Apple, Cupertino. Califronia, USA) dedicated to the study
Measured: baseline
Impact of several factors (dermatosis, area, gender, age) on the molecular profiles of the epidermis
Characteristic peak mass intensities - SpiderMass
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start13 Dec 2019
- Primary completion2 Feb 2023
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Subject group : Exploratory study, monocentric and comparative performed at: * control subject group, divided in 5 subgroups : * A': associated to acne of the face subgroup * B' : associated to atopic dermatitis of the upper limb subgroup * C' : associated to vulgar plaque psoriasis subgroup * D' : associated to telangiectasic erythrocouperosis papule of the face (rosacea) subgroup * E' : associated to seborrheic dermatitis of scalp subgroup * subject group with dermatitis, divided in 5 subgroups : * A: acne of the face subgroup * B : atopic dermatitis of the upper limb subgroup * C : vulgar plaque psoriasis subgroup * D : telangiectasic erythrocouperosis papule of the face (rosacea) subgroup * E : seborrheic dermatitis of scalp subgroup Visit number : It includes 1 unique visit to the Skin Research Center, Toulouse, France. The maximum duration of participation for a subject is 1 day (around 2 hours).
- Masking
- None (open label)
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Dermo Cosmetique
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thérèse NOCERA, Mrs, Principal investigator, Centre de Recherche sur La Peau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472546
- Sponsor's protocol ID
- SMPATHO01
- Other IDs
- 2019-A02105-52
- Status last verified
- Jun 2024
- First submitted
- 5 Jun 2020
- Last updated
- 7 Jun 2024
- 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 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the SpiderMass(TM) for in Vivo and Real Time Mass Spectrometry Analysis of Subject's Epidermis Suffering From Chronic Inflammatory Dermatosis Compared to Control Groups
- ClinicalTrials.gov ID
- NCT04472546
- Acronym / sponsor ID
- SMPATHO01
- Conditions
- Acne, Atopic Dermatitis, Psoriasis Vulgaris, Rosacea, Seborrheic Dermatitis, Healthy
- Keywords
- dermatitis, acne of the face, Atopic Dermatitis of the upper limb, Psoriasis Vulgaris, Rosacea, seborrheic dermatitis, SpiderMass, Lipid Index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Pierre Fabre Dermo CosmetiqueIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 15 Jul 2020 (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 physiological states of the skin are characterized by a certain homeostasis linked to the balance of the metabolic pathways. When these pathways are deregulated, the proteic, lipidic and metabolic is affected. It is thus possible to follow a change in the state of the skin by looking at change in the associated molecular profile.
The PRISM laboratory (INSERM U1192) in Lille has developed an innovative system laser called SpiderMass composed of 4 parts:
- A laser used for the micro-sampling of material in vivo,
- A transport transfer line of the ablated particles,
- A mass spectrometer that analyzes them in real time and generates the molecular profiles of the epidermis,
- A data analysis procedure.
The SpiderMass(TM) is of great interest for the study of the skin because it allows non-invasive vivo characterization, and therefore without biopsy or sample preparation. In addition, it will complement techniques already used in the research center such as FTIR spectroscopy. Indeed, in acne studies the FTIR allows to obtain only the Fatty Acid Triglycerid ratio while the SpiderMass permits to detail these lipid classes by each observed molecule on the surface of the skin and follow their evolution.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subject group : Exploratory study, monocentric and comparative performed at: * control subject group, divided in 5 subgroups : * A': associated to acne of the face subgroup * B' : associated to atopic dermatitis of the upper limb subgroup * C' : associated to vulgar plaque psoriasis subgroup * D' : associated to telangiectasic erythrocouperosis papule of the face (rosacea) subgroup * E' : associated to seborrheic dermatitis of scalp subgroup * subject group with dermatitis, divided in 5 subgroups : * A: acne of the face subgroup * B : atopic dermatitis of the upper limb subgroup * C : vulgar plaque psoriasis subgroup * D : telangiectasic erythrocouperosis papule of the face (rosacea) subgroup * E : seborrheic dermatitis of scalp subgroup Visit number : It includes 1 unique visit to the Skin Research Center, Toulouse, France. The maximum duration of participation for a subject is 1 day (around 2 hours).
| Arm | Type | Receives |
|---|---|---|
| Control subject group | Other | Other: in-vivo mesure, Other: Scotch, Other: Lipid index, Other: Absorbant paper, Other: Hydratation Index, Other: TransEpidermal Water LossDivided in 5 subgroups : * A': associated to acne of the face subgroup * B' : associated to atopic dermatitis of the upper limb subgroup * C' : associated to vulgar plaque psoriasis subgroup * D' : associated to telangiectasic erythrocouperosis papule of the face (rosacea) subgroup * E' : associated to seborrheic dermatitis of scalp subgroup |
| Subject group with dermatitis | Other | Other: in-vivo mesure, Other: Scotch, Other: Lipid index, Other: Absorbant paper, Other: Hydratation Index, Other: TransEpidermal Water LossDivided in 5 subgroups : * A : acne of the face subgroup * B : Atopic dermatitis of the upper limb subgroup * C : Vulgar plaque psoriasis subgroup * D : Telangiectasic erythrocouperosis papule of the face (rosacea) subgroup * E : Seborrheic dermatitis of scalp subgroup |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| in-vivo mesureAlso: SpiderMass mesure* for acne of the face subgroup and its associated control : face and inner side of the forearm * for atopic dermatitis of the upper limb subgroup and its associated control: upper limb (hand excluded) and inner side of the forearm * for vulgar plaque psoriasis subgroup and its associated control: upper limb (hand excluded) or lower limb and inner side of the forearm * for telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: face and inner side of the forearm * for seborrheic dermatitis of scalp subgroup and its associated control: scalp and inner side of the forearm | Other | Control subject group, Subject group with dermatitis |
| Scotch* for acne of the face subgroup and its associated control : face and inner side of the forearm * for atopic dermatitis of the upper limb subgroup and its associated control: upper limb (hand excluded) and inner side of the forearm * for vulgar plaque psoriasis subgroup and its associated control: upper limb (hand excluded) or lower limb and inner side of the forearm * for telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: face and inner side of the forearm * for seborrheic dermatitis of scalp subgroup and its associated control: scalp and inner side of the forearm | Other | Control subject group, Subject group with dermatitis |
| Lipid index* for acne of the face subgroup and its associated control : face * for seborrheic dermatitis of scalp subgroup and its associated control: scalp * for telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: face | Other | Control subject group, Subject group with dermatitis |
| Absorbant paper* for acne of the face subgroup and its associated control : face * for seborrheic dermatitis of scalp subgroup and its associated control: scalp * for telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: forehead | Other | Control subject group, Subject group with dermatitis |
| Hydratation Index-for atopic dermatitis of the upper limb subgroup and its associated control: upper limb (hand excluded) | Other | Control subject group, Subject group with dermatitis |
| TransEpidermal Water Loss-for atopic dermatitis of the upper limb subgroup and its associated control: upper limb (hand excluded) | Other | Control subject group, Subject group with dermatitis |
Primary outcome
Signals and molecular profiles (including lipid) of the epidermis
Time frame: baseline
Defined by characteristic peak mass intensities - SpiderMass
Molecular profiles (including lipid) of the epidermis according to sampling method and the measurements of the signals obtained method
Time frame: baseline
* sampling method - absorbant paper, in vivo and / or by scotch * measurements of the signals obtained -in vivo or FTIR
Cutaneous hydratation for atopic dermatitis subgroup and its associated control
Time frame: baseline
By hydratation index - Corneometer
State of the cutaneous barrier for atopic dermatitis and corresponding control volunteers
Time frame: baseline
Rate of the Trans Epithelial Water Loss (TEWL) by arbitrary units with an Aquaflux system (Biox Systems Ltd, London. UK)
Global lipid quantity measured on face acnea, scalp seborrheic dermatitis, face rosacea (papulotelangiectasic stage of erythrocouperosis) and corresponding control volunteers
Time frame: baseline
Global sebum level measurement expressed in arbitrary index with a Sebumeter SM815 system (Courage+Khazaka electronic GmbH, Köln. Germany)
Skin state evaluation on the lesional and perilesional areas
Time frame: baseline
Illustrative descriptions of the skin state with photographs, taken by an iPhone 6S (Apple, Cupertino. Califronia, USA) dedicated to the study
Impact of several factors (dermatosis, area, gender, age) on the molecular profiles of the epidermis
Time frame: baseline
Characteristic peak mass intensities - SpiderMass
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 7 Jun 2024.
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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.
Thérèse NOCERA, Mrs principal investigator
Centre de Recherche sur La Peau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing in-vivo mesure, Scotch and Lipid index in people with Acne and Atopic Dermatitis, run by Pierre Fabre Dermo Cosmetique 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?
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 7 Jun 2024. 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?
Signals and molecular profiles (including lipid) of the epidermis (time frame: baseline). The study lists 7 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 7 Jun 2024.