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OpenTrials
Completed

NCT Number: NCT05057351

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

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

Completed

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Key information

Conditions

Mild to Moderate Atopic Dermatitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Complife Italia S.r.l.

San Martino Siccomario, 27028, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Isopentenyltheophylline 0.44% + Glycerin 4.56%

Other

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

Glycerin 4.56%

Other

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

Primary outcomes

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

    Time frame: 7, 14 and 28 days

Sponsors and collaborators

Lead sponsor

Greenpharma S.A.S.

Other

Collaborators

  • Complife Italia Srl

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Sep 27, 2021
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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