Cutaneous PatchNCT01816542
Evaluation of Irritancy/Allergic Sensitivity to Natural Personal-care Products by Patch Tests
A study testing patch tests on healthy skin in people with Cutaneous Patch and Dermatitis, run by Mother's Choice Ltd at 1 site in Israel.
Trial summary
The purpose of the study is to determine if any of Mother's Choice' all-natural personal-care products cause either irritation or allergic reaction when applied to both normal or sensitive skin. Each product will be tested on the skin using patch tests. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cutaneous Patch, Dermatitis, Allergy
- What is being tested?
- patch tests on healthy skin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2013to Sep 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
Who cannot join
- Pregnant subjects
- Subjects with an allergy or a skin disease which interferes with the proper results of the tests.
- Subjects who are taking medications which can interfere with the proper results of the tests. For example: systemic corticosteroids, topical steroids applied to the test area.
- Subjects with sun or phototherapy induced tanning at the test area.
- Subject who had been participating in allergy tests within eight weeks prior to the present tests.
Trial locations and contacts
1 site in 1 country.
Liran Horev, MD contact
Israel1 site
Department of Dermatology, Hadassah University Hospital
Jerusalem, 91120
About this study
Official title: Dermatologically Tested - Patch Tests - to Assess the Irritancy/Allergic Sensitivity of the Natural Personal-care Products Developed by "Mother's Choice".
The purpose of the study is to determine if any of Mother's Choice' all-natural personal-care products cause either irritation or allergic reaction when applied to both normal or sensitive skin.
Each product will be tested on the skin using patch tests.
Read the detailed description
Volunteers will be seen on Day #0 and the study purpose will be explained. Each volunteer will be interviewed to determine if he/she has any exclusion criteria.
If there is no contraindication, and agreement is achieved,consent forms will be signed.
Volunteers will be examined by a lactic acid test to determine if he/she has normal or sensitive skin. In this test, a Finn's cell (plastic cell, size 1*1 cm) with lactic acid (50 microliter, 10%w/v) will be placed on the volunteer's cheek for ten minutes. The volunteer will be defined as "sensitive" or "normal" according to the degree of discomfort they report.
Patch-tests will be performed in the standard method. The materials to be tested will be placed in Finn's cells and attached to the participants healthy skin's back by a plaster (Micropore).The chambers will be left on the skin for 48 hours. The test will be read by a specialist one hour after chambers' removal and 48 hours afterwards. Any erythema,edema, blisters, pustules or erosions on the skin in the patch area will be considered a positive response, and will be evaluated by clinical tools as being of the irritant or the allergic type. in case of uncertainty we may use a confocal microscope for in vivo diagnosis.
Ingredients: appropriate concentrations and solvents of the test materials will be prepared according to accepted standards (refer to: Anton C. De Groot: Patch Testing, 3ed Edition, Wapserveen, The Netherlands, 2009).Leave on products will be tested 'as is'. Rinse off products will be diluted to 5% and 0.5%.
If the skin stays normal after the patch removal, it means that contact with the material did not cause allergy or irritation.
- Being tested
- patch tests on healthy skin
- Keywords
- patch-testing, personal-care, cosmetic, dermatitis, allergy, sensitive skin
- Medical subject headings
- Plaque, Amyloid, Dermatitis, Hypersensitivity, Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patch tests on healthy skinOther
Patches will be placed on healthy skin.
| Study group | Role | What they receive |
|---|---|---|
| patch tests on healthy skin | Other | Not described Receives: Other: patch tests on healthy skin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with positive reactions, number of positive reactions.
Erythema, edema, blisters, pustules or erosions on the skin in the patch area will be considered a positive response.
If the skin is normal after the patch removal, it means that contact with the material do not cause allergy or irritation.
Measured: One week
Secondary outcomes (1)
Number of irritant versus allergic reactions, as determined by confocal microscopy.
In case of a positive reaction, it will be examined by confocal microscopy, by a specialist, to determine whether the reaction is irritant or allergic in nature.
Measured: On the spot
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startJun 2013
- Primary completionAug 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cutaneous PatchStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mother's Choice Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arieh Ingber, MD Prof., Principal investigator, Hadassah University Hospital, Department of DermatologyLiran Horev, MD, Principal investigator, Hadassah University Hospital, Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816542
- Sponsor's protocol ID
- MC-2013-PT-BA
- Status last verified
- Mar 2013
- First submitted
- 12 Feb 2013
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mahmood T, Akhtar N. Short term study of human skin irritation by single application closed patch test: assessment of four multiple emulsion formulations loaded with botanical extracts. Cutan Ocul Toxicol. 2013 Mar;32(1):35-40. doi: 10.3109/15569527.2012.700472. Epub 2012 Jul 5.
PubMed 22765292Davies RF, Johnston GA. New and emerging cosmetic allergens. Clin Dermatol. 2011 May-Jun;29(3):311-5. doi: 10.1016/j.clindermatol.2010.11.010.
PubMed 21496740
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dermatologically Tested - Patch Tests - to Assess the Irritancy/Allergic Sensitivity of the Natural Personal-care Products Developed by "Mother's Choice".
- ClinicalTrials.gov ID
- NCT01816542
- Acronym / sponsor ID
- MC-2013-PT-BA
- Keywords
- patch-testing, personal-care, cosmetic, dermatitis, allergy, sensitive skin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mother's Choice LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 22 Mar 2013 (estimated)
- 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 purpose of the study is to determine if any of Mother's Choice' all-natural personal-care products cause either irritation or allergic reaction when applied to both normal or sensitive skin.
Each product will be tested on the skin using patch tests.
Detailed description
Volunteers will be seen on Day #0 and the study purpose will be explained. Each volunteer will be interviewed to determine if he/she has any exclusion criteria.
If there is no contraindication, and agreement is achieved,consent forms will be signed.
Volunteers will be examined by a lactic acid test to determine if he/she has normal or sensitive skin. In this test, a Finn's cell (plastic cell, size 1*1 cm) with lactic acid (50 microliter, 10%w/v) will be placed on the volunteer's cheek for ten minutes. The volunteer will be defined as "sensitive" or "normal" according to the degree of discomfort they report.
Patch-tests will be performed in the standard method. The materials to be tested will be placed in Finn's cells and attached to the participants healthy skin's back by a plaster (Micropore).The chambers will be left on the skin for 48 hours. The test will be read by a specialist one hour after chambers' removal and 48 hours afterwards. Any erythema,edema, blisters, pustules or erosions on the skin in the patch area will be considered a positive response, and will be evaluated by clinical tools as being of the irritant or the allergic type. in case of uncertainty we may use a confocal microscope for in vivo diagnosis.
Ingredients: appropriate concentrations and solvents of the test materials will be prepared according to accepted standards (refer to: Anton C. De Groot: Patch Testing, 3ed Edition, Wapserveen, The Netherlands, 2009).Leave on products will be tested 'as is'. Rinse off products will be diluted to 5% and 0.5%.
If the skin stays normal after the patch removal, it means that contact with the material did not cause allergy or irritation.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patch tests on healthy skin | Other | Other: patch tests on healthy skin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults
Key exclusion criteria (5 listed)
- Pregnant subjects
- Subjects with an allergy or a skin disease which interferes with the proper results of the tests.
- Subjects who are taking medications which can interfere with the proper results of the tests. For example: systemic corticosteroids, topical steroids applied to the test area.
- Subjects with sun or phototherapy induced tanning at the test area.
- Subject who had been participating in allergy tests within eight weeks prior to the present tests.
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 |
|---|---|---|
| patch tests on healthy skinPatches will be placed on healthy skin. | Other | patch tests on healthy skin |
Primary outcome
Number of participants with positive reactions, number of positive reactions.
Time frame: One week
Erythema, edema, blisters, pustules or erosions on the skin in the patch area will be considered a positive response. If the skin is normal after the patch removal, it means that contact with the material do not cause allergy or irritation.
1 secondary outcome
Number of irritant versus allergic reactions, as determined by confocal microscopy.
Time frame: On the spot
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
- Background: PubMed 22765292Mahmood T, Akhtar N. Short term study of human skin irritation by single application closed patch test: assessment of four multiple emulsion formulations loaded with botanical extracts. Cutan Ocul Toxicol. 2013 Mar;32(1):35-40. doi: 10.3109/15569527.2012.700472. Epub 2012 Jul 5.
- Background: PubMed 21496740Davies RF, Johnston GA. New and emerging cosmetic allergens. Clin Dermatol. 2011 May-Jun;29(3):311-5. doi: 10.1016/j.clindermatol.2010.11.010.
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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.
Liran Horev, MD contact
Arieh Ingber, MD Prof. principal investigator
Hadassah University Hospital, Department of Dermatology
Liran Horev, MD principal investigator
Hadassah University Hospital, Department of Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patch tests on healthy skin in people with Cutaneous Patch and Dermatitis, run by Mother's Choice Ltd at 1 site in Israel.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Mar 2013. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tova Silberstein, Dr. (972-25610752, clinical.mc.2013@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with positive reactions, number of positive reactions. (time frame: One week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01816542, which also lists 2 linked publications.
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 22 Mar 2013.