Mild to Moderate Atopic DermatitisNCT05057351
A Controlled Study to Evaluate the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis
A study testing Isopentenyltheophylline 0.44% + Glycerin 4.56% and Glycerin 4.56% in people with Mild to Moderate Atopic Dermatitis, run by Greenpharma S.A.S. at 1 site in Italy.
Trial summary
Evaluation of safety and clinical efficacy of an active ingredient versus placebo for the treatment of mild to moderate Atopic Dermatitis (AD) adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild to Moderate Atopic Dermatitis
- What is being tested?
- Isopentenyltheophylline 0.44% + Glycerin 4.56% and Glycerin 4.56%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2020to 31 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Isopentenyltheophylline 0.44% + Glycerin 4.56%, Glycerin 4.56%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Active ingredient | Experimental | Isopentenyltheophylline 0.44% + Glycerin 4.56% Receives: Other: Isopentenyltheophylline 0.44% + Glycerin 4.56% |
| Placebo | Placebo comparator | Glycerin 4.56% Receives: Other: Glycerin 4.56% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of Atopic Dermatitis as assessed using the SCORing Atopic Dermatitis (SCORAD)
Measured: 7, 14 and 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Sep 2020
- Primary completion30 Nov 2020
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild to Moderate Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single center, randomized, double-blind, placebo-controlled, parallel group study, carried on 2 groups of 22 subjects.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greenpharma S.A.S.
- Sponsor type
- University, hospital or other
- Collaborators
- Complife Italia Srl
- Responsible party
- Sponsor
- Investigators
- Gloria Roveda, MD, Principal investigator, Complife Italia Srl
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057351
- Sponsor's protocol ID
- H.E.HU.AD.NSO05.066.05.00
- Status last verified
- Sep 2021
- First submitted
- 8 Sep 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05057351
- Acronym / sponsor ID
- H.E.HU.AD.NSO05.066.05.00
- Conditions
- Mild to Moderate Atopic Dermatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Greenpharma S.A.S.University, hospital or other
- Collaborators
- Complife Italia Srl
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 27 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of safety and clinical efficacy of an active ingredient versus placebo for the treatment of mild to moderate Atopic Dermatitis (AD) adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single center, randomized, double-blind, placebo-controlled, parallel group study, carried on 2 groups of 22 subjects.
| Arm | Type | Receives |
|---|---|---|
| Active ingredient | Experimental | Other: Isopentenyltheophylline 0.44% + Glycerin 4.56%Isopentenyltheophylline 0.44% + Glycerin 4.56% |
| Placebo | Placebo comparator | Other: Glycerin 4.56%Glycerin 4.56% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isopentenyltheophylline 0.44% + Glycerin 4.56%Application of topical cream twice a day on the area affected by Atopic Dermatitis | Other | Active ingredient |
| Glycerin 4.56%Application of topical cream twice a day on the area affected by Atopic Dermatitis | Other | Placebo |
Primary outcome
Change in severity of Atopic Dermatitis as assessed using the SCORing Atopic Dermatitis (SCORAD)
Time frame: 7, 14 and 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gloria Roveda, MD principal investigator
Complife Italia Srl
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isopentenyltheophylline 0.44% + Glycerin 4.56% and Glycerin 4.56% in people with Mild to Moderate Atopic Dermatitis, run by Greenpharma S.A.S. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in severity of Atopic Dermatitis as assessed using the SCORing Atopic Dermatitis (SCORAD) (time frame: 7, 14 and 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.