A Controlled Study to Evaluate the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis
NCT ID: NCT05057351
Last Updated: 2021-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
44 participants
INTERVENTIONAL
2020-09-01
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Active ingredient
Isopentenyltheophylline 0.44% + Glycerin 4.56%
Isopentenyltheophylline 0.44% + Glycerin 4.56%
Application of topical cream twice a day on the area affected by Atopic Dermatitis
Placebo
Glycerin 4.56%
Glycerin 4.56%
Application of topical cream twice a day on the area affected by Atopic Dermatitis
Interventions
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Isopentenyltheophylline 0.44% + Glycerin 4.56%
Application of topical cream twice a day on the area affected by Atopic Dermatitis
Glycerin 4.56%
Application of topical cream twice a day on the area affected by Atopic Dermatitis
Eligibility Criteria
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Inclusion Criteria
* Phototype I to IV
* Mild to moderate SCORAD (between 15 and 25)
Exclusion Criteria
* Positive history for atopy or hypersensitive skin
* Subjects under systemically pharmacological treatment
* Subjects under locally pharmacological treatment on the skin area monitored during the test
* Subjects with congenital or acquired immunodeficiency
* Subjects under treatment with food supplements which could interfere with the functionality of the product under study
* Subjects which show other skin alterations on the monitored area except for acne lesions
* Subjects with known or suspected sensitization to one or more test formulation ingredients
18 Years
ALL
No
Sponsors
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Complife Italia S.r.l
UNKNOWN
Greenpharma S.A.S.
OTHER
Responsible Party
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Principal Investigators
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Gloria Roveda, MD
Role: PRINCIPAL_INVESTIGATOR
Complife Italia S.r.l
Locations
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Complife Italia S.r.l.
San Martino Siccomario, , Italy
Countries
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Other Identifiers
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H.E.HU.AD.NSO05.066.05.00
Identifier Type: -
Identifier Source: org_study_id
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