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A Controlled Study to Evaluate the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis

Primary Purpose

Mild to Moderate Atopic Dermatitis

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Isopentenyltheophylline 0.44% + Glycerin 4.56%

Glycerin 4.56%

About this trial

This is an interventional treatment trial for Mild to Moderate Atopic Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Main Inclusion Criteria:

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

Main 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

Sites / Locations

Complife Italia S.r.l.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active ingredient

Placebo

Arm Description

Isopentenyltheophylline 0.44% + Glycerin 4.56%

Glycerin 4.56%

Outcomes

Primary Outcome Measures

Change in severity of Atopic Dermatitis as assessed using the SCORing Atopic Dermatitis (SCORAD)

Secondary Outcome Measures

Full Information

NCT ID

NCT05057351

First Posted

September 8, 2021

Last Updated

September 24, 2021

Sponsor

Greenpharma S.A.S.

Collaborators

Complife Italia S.r.l

1. Study Identification

Unique Protocol Identification Number

NCT05057351

Brief Title

A Controlled Study to Evaluate the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis

Official Title

Randomized, Double Blind, Clinical Study for Evaluating the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis. Controlled Study vs Placebo

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

November 30, 2020 (Actual)

Study Completion Date

March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Greenpharma S.A.S.

Collaborators

Complife Italia S.r.l

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mild to Moderate Atopic Dermatitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active ingredient

Arm Type

Experimental

Arm Description

Isopentenyltheophylline 0.44% + Glycerin 4.56%

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Glycerin 4.56%

Intervention Type

Other

Intervention Name(s)

Isopentenyltheophylline 0.44% + Glycerin 4.56%

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Glycerin 4.56%

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in severity of Atopic Dermatitis as assessed using the SCORing Atopic Dermatitis (SCORAD)

Time Frame

7, 14 and 28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Main Inclusion Criteria: Good general health Phototype I to IV Mild to moderate SCORAD (between 15 and 25) Main 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gloria Roveda, MD

Organizational Affiliation

Complife Italia S.r.l

Official's Role

Principal Investigator

Facility Information:

Facility Name

Complife Italia S.r.l.

City

San Martino Siccomario

ZIP/Postal Code

27028

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Controlled Study to Evaluate the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis

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