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

NCT05057351 | Completed

• 1 other identifier: H.E.HU.AD.NSO05.066.05.00
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild to Moderate Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

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

  7, 14 and 28 days

Study Arms (2)

Active ingredient

EXPERIMENTAL

Isopentenyltheophylline 0.44% + Glycerin 4.56%

Other: Isopentenyltheophylline 0.44% + Glycerin 4.56%

Placebo

PLACEBO COMPARATOR

Glycerin 4.56%

Other: Glycerin 4.56%

Interventions

Isopentenyltheophylline 0.44% + Glycerin 4.56% OTHER

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

Active ingredient

Glycerin 4.56% OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Greenpharma S.A.S.: lead
• Complife Italia S.r.l: collaborator

Study Sites (1)

Complife Italia S.r.l.

San Martino Siccomario, 27028, Italy

Location

Study Officials

• Gloria Roveda, MD

  Complife Italia S.r.l

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 27, 2021
• Study Start: September 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: March 31, 2021
• Last Updated: September 27, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)