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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-03-31

Brief Summary

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Evaluation of safety and clinical efficacy of an active ingredient versus placebo for the treatment of mild to moderate Atopic Dermatitis (AD) adults.

Detailed Description

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Conditions

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Mild to Moderate Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Single center, randomized, double-blind, placebo-controlled, parallel group study, carried on 2 groups of 22 subjects.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active ingredient

Isopentenyltheophylline 0.44% + Glycerin 4.56%

Group Type EXPERIMENTAL

Isopentenyltheophylline 0.44% + Glycerin 4.56%

Intervention Type OTHER

Application of topical cream twice a day on the area affected by Atopic Dermatitis

Placebo

Glycerin 4.56%

Group Type PLACEBO_COMPARATOR

Glycerin 4.56%

Intervention Type OTHER

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

Intervention Type OTHER

Glycerin 4.56%

Application of topical cream twice a day on the area affected by Atopic Dermatitis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Good general health
* Phototype I to IV
* Mild to moderate SCORAD (between 15 and 25)

Exclusion Criteria

* Pregnant/breastfeeding female or who have planned a pregnancy during the study period
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Complife Italia S.r.l

UNKNOWN

Sponsor Role collaborator

Greenpharma S.A.S.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Italy

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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