Acne VulgarisNCT05855629

"A Comparative Clinical Evaluation of the Efficacy of Topical Adapalene, Benzoyl Peroxide Gel, Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule, and Their Fixed Combination in Mild to Moderate Acne Vulgaris Patients."

A study testing Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule and Topical Adapalene, Benzoyl Peroxide Gel in people with Acne Vulgaris, run by Treatment and Diagnostic Center of Private Enterprise "Asklepiy" at 1 site in Ukraine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The study aims to conduct a comparative clinical evaluation of the effectiveness of a fixed topical combination of adapalene with benzoyl peroxide in the form of a gel, a fixed combination of Lactobacillus rhamnosus, D-chiro-inositol and inulin in the form of capsules and their combination in patients with acne… Read more about this study

Who is it for?: Ages 18 to 27 yearsHealthy volunteers can take part
Conditions the study is for: Acne Vulgaris
What is being tested?: Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule and Topical Adapalene, Benzoyl Peroxide Gel
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 1 siteUkraine
Study dates: 18 Feb 2022to 30 Jul 2023
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 to 27 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Patients with mild to moderate level of Acne Vulgaris

Who cannot join

Pregnancy

Trial locations and contacts

1 site in 1 country.

Ukraine1 site

TDC PE "Asklepiy"
Uzhhorod, Zakarpattia Oblast, 88000

Other trials in Ukraine

About this study

Conditions: Acne Vulgaris
Being tested: Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule, Topical Adapalene, Benzoyl Peroxide Gel
Medical subject headings: Acne Vulgaris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin CapsuleDietary supplement
Lactobacillus Rhamnosus 1,5 х 10*9, Inulin 25mg, D-chiro-inositol 250mg
Topical Adapalene, Benzoyl Peroxide GelDrug
Adapalene 1mg/g, Benzoyl Peroxide 25mg/ml

Study groups in NCT05855629
Study group	Role	What they receive
Topical Adapalene, Benzoyl Peroxide Gel	Other	Not described Receives: Drug: Topical Adapalene, Benzoyl Peroxide Gel
Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule	Other	Not described Receives: Dietary Supplement: Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule
Topical Adapalene,Benzoyl Peroxide Gel,Oral Lactobacillus Rhamnosus,D-chiro-inositol,Inulin Capsule	Other	Not described Receives: Dietary Supplement: Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule; Drug: Topical Adapalene, Benzoyl Peroxide Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

GAGS (Global Acne Grading System)
The primary end point of the study is the intensity of acne manifestations according to the GAGS scale
Measured: 180 days

Secondary outcomes (1)

IGA (Investigator Global Assessment)
The secondary end point of the study is the intensity of acne manifestations according to the IGA scale
Measured: 180 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Feb 202230 Jul 2023

First posted11 May 2023
Study start18 Feb 2022
Primary completion12 Jun 2023 (estimated)
Study completion30 Jul 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acne VulgarisStudies 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
Masking: None (open label)
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05855629
Sponsor's protocol ID: EDA1370
Status last verified: May 2023
First submitted: 4 May 2023
Last updated: 11 May 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

All Acne Vulgaris trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: "A Comparative Clinical Evaluation of the Efficacy of Topical Adapalene, Benzoyl Peroxide Gel, Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule, and Their Fixed Combination in Mild to Moderate Acne Vulgaris Patients."
ClinicalTrials.gov ID: NCT05855629
Acronym / sponsor ID: EDA1370
Conditions: Acne Vulgaris
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 59 participants (actual)
Lead sponsor: Treatment and Diagnostic Center of Private Enterprise "Asklepiy"University, hospital or other
Collaborators: delta medical promotions ag
Study start: 18 Feb 2022 (actual)
Primary completion: 12 Jun 2023 (estimated)
Study completion: 30 Jul 2023 (estimated)
First posted: 11 May 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Topical Adapalene, Benzoyl Peroxide Gel	Other	Drug: Topical Adapalene, Benzoyl Peroxide Gel
Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule	Other	Dietary Supplement: Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule
Topical Adapalene,Benzoyl Peroxide Gel,Oral Lactobacillus Rhamnosus,D-chiro-inositol,Inulin Capsule	Other	Dietary Supplement: Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule, Drug: Topical Adapalene, Benzoyl Peroxide Gel

Who may qualify

Ages: 18 to 27 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Patients with mild to moderate level of Acne Vulgaris

Key exclusion criteria (1 listed)

Pregnancy

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
Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin CapsuleLactobacillus Rhamnosus 1,5 х 10*9, Inulin 25mg, D-chiro-inositol 250mg	Dietary supplement	Oral Lactobacillus Rhamnosus, D-chiro-inositol, Inulin Capsule, Topical Adapalene,Benzoyl Peroxide Gel,Oral Lactobacillus Rhamnosus,D-chiro-inositol,Inulin Capsule
Topical Adapalene, Benzoyl Peroxide GelAdapalene 1mg/g, Benzoyl Peroxide 25mg/ml	Drug	Topical Adapalene, Benzoyl Peroxide Gel, Topical Adapalene,Benzoyl Peroxide Gel,Oral Lactobacillus Rhamnosus,D-chiro-inositol,Inulin Capsule

Primary outcome

GAGS (Global Acne Grading System)
Time frame: 180 days
The primary end point of the study is the intensity of acne manifestations according to the GAGS scale

1 secondary outcome

IGA (Investigator Global Assessment)
Time frame: 180 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.

Related trials for Acne Vulgaris

Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 11 May 2023. 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 Ukraine. 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. 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?

Results are not available in the source record.

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?

GAGS (Global Acne Grading System) (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05855629.

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 11 May 2023.