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

September 24, 2021 updated by: Greenpharma S.A.S.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • San Martino Siccomario, Italy, 27028
        • Complife Italia S.r.l.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Active ingredient
Isopentenyltheophylline 0.44% + Glycerin 4.56%
Other: Isopentenyltheophylline 0.44% + Glycerin 4.56%
Application of topical cream twice a day on the area affected by Atopic Dermatitis
PLACEBO_COMPARATOR: Placebo
Glycerin 4.56%
Other: Glycerin 4.56%
Application of topical cream twice a day on the area affected by Atopic Dermatitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in severity of Atopic Dermatitis as assessed using the SCORing Atopic Dermatitis (SCORAD)
Time Frame: 7, 14 and 28 days
7, 14 and 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Greenpharma S.A.S.

Collaborators

Complife Italia S.r.l

Investigators

  • Principal Investigator: Gloria Roveda, MD, Complife Italia S.r.l

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2020

Primary Completion (ACTUAL)

November 30, 2020

Study Completion (ACTUAL)

March 31, 2021

Study Registration Dates

First Submitted

September 8, 2021

First Submitted That Met QC Criteria

September 24, 2021

First Posted (ACTUAL)

September 27, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2021

Last Update Submitted That Met QC Criteria

September 24, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H.E.HU.AD.NSO05.066.05.00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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