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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05057351

Enrollment

Registered

2021-09-27

Start date

2020-09-01

Completion date

2021-03-31

Last updated

2021-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to Moderate Atopic Dermatitis

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.

Interventions

OTHERIsopentenyltheophylline 0.44% + Glycerin 4.56%

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

OTHERGlycerin 4.56%

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026