Study on the Effectiveness of Clindamycin and Tretinoin Gel for Treating Acne in Patients

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What is this study about?

This clinical trial is focused on studying the treatment of acne vulgaris, a common skin condition that causes pimples and spots, especially on the face. The study will compare two different gels that contain the active ingredients clindamycin and tretinoin. These ingredients are often used to treat acne by reducing bacteria and promoting skin cell turnover. The trial will involve three groups: one using the test product, Clindamycin + Tretinoin/Verisfield gel, another using the reference product, Acnatac®/Meda gel, and a third group using a placebo.

The purpose of the study is to determine if the test product is as effective as the reference product in treating acne. Participants will apply the gel to their face for a period of 12 weeks. During this time, changes in the number of acne lesions, which include both inflamed spots like papules and pustules, and non-inflamed spots like open and closed comedones, will be monitored. The study aims to show that both the test and reference products are better than the placebo in reducing acne symptoms.

Throughout the study, participants will be observed for any side effects, such as skin reactions like redness, dryness, or itching. The study will also track any serious or non-serious adverse effects that may occur. The goal is to ensure the safety and effectiveness of the treatment for those suffering from acne vulgaris.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a clinical diagnosis of facial acne vulgaris, with specific lesion counts required.

Participants must be between 12 and 40 years old and in good general health. A negative pregnancy test is required for females of childbearing potential.

2 treatment allocation

Participants are randomly assigned to one of three groups: the test product group, the reference product group, or the placebo group.

The test product is a gel containing clindamycin and tretinoin at concentrations of 1% and 0.025%, respectively.

3 treatment application

Participants apply the assigned gel externally to the face once daily for 12 weeks.

The application should be consistent, avoiding the use of other facial products except for the study-supplied cleanser and sunscreen.

4 follow-up visits

Regular follow-up visits are scheduled to monitor progress and any side effects. These visits assess changes in acne lesions and any reactions at the application site.

Participants are evaluated for any adverse effects, such as redness, dryness, or itching.

5 final evaluation

At the end of the 12-week period, a final evaluation is conducted to measure the percent change in acne lesions from the start of the study.

The effectiveness of the treatment is assessed, and any long-term reactions are documented.

Who Can Join the Study?

Must be a male or a non-pregnant, non-breastfeeding female aged between 12 and 40 years.
Must have a clinical diagnosis of mild to severe facial acne vulgaris, which is a common skin condition that causes pimples.
Must have at least 25 non-inflammatory lesions (like blackheads and whiteheads) and at least 20 inflammatory lesions (like red bumps and pus-filled spots) on the face, but no more than 2 nodulocystic lesions (which are larger, deeper bumps).
Must have been using the same type and brand of non-medicated makeup, cleanser, or other facial and hair products for at least 14 days before starting the study and agree to continue using them without changes during the study.
Must be in good general health, without any condition that could affect the study or pose a risk to the participant.
If female and of childbearing potential, must agree to use an acceptable form of birth control during the study and have a negative pregnancy test at the start.
Must be willing and able to apply the study treatment as directed, follow study instructions, and attend scheduled visits.
Must be able to understand and willing to provide written consent to participate in the study.
Must agree not to use any other facial products, acne medications, or antibiotics on the face during the 12-week treatment period, except for the study-provided cleanser and sunscreen.

Who Cannot Join the Study?

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a known allergy to any of the study medications or their ingredients are excluded.
Patients who have used other acne treatments within a certain period before the study starts are not eligible.
People with certain skin conditions that might interfere with the study results cannot join.
Participants who have taken part in another clinical trial recently are not allowed.
Individuals with a history of certain medical conditions that could affect the study outcomes are excluded.
Patients who are unable to follow the study procedures or attend scheduled visits cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
General Hospital Of Western Attica Agia Varvara	Agia Varvara	Greece

Other Sites

Site Name	City	Country
Ippokratio General Hospital Of Thessaloniki	Thessaloniki	Greece
Evangelismos S.A.	Athens	Greece
401 General Military Hospital Of Athens	Athens	Greece
General Hospital Of Thessaloniki Papageorgiou	Thessaloniki	Greece
Andreas Syngros Hospital Of Venereal And Dermatological Diseases	Athens	Greece
General University Hospital Of Patras	Patras	Greece
Ugxcnqmrht Geihhkd Hmjpdwdg Apukqjm	Athens	Greece

Trial status

Country	Status	Recruitment Start
Greece	Not recruiting	01.01.2023

Trial locations

Investigated drugs:

Clindamycin + Tretinoin/Verisfield Gel is a topical treatment used in this study to treat acne vulgaris. It combines two active ingredients: clindamycin, an antibiotic that helps reduce bacteria and inflammation, and tretinoin, a form of vitamin A that helps the skin renew itself more quickly. This gel is being tested to see if it is as effective as the reference product in reducing acne lesions.

Acnatac®/Meda Gel is the reference product in this study, also used for treating acne vulgaris. It contains the same active ingredients as the test product: clindamycin and tretinoin. The study aims to compare the effectiveness of this gel with the test product to ensure they provide similar benefits in reducing acne symptoms.

Acne Vulgaris – Acne vulgaris is a common skin condition that primarily affects the face, back, and shoulders. It is characterized by the presence of pimples, blackheads, and whiteheads, which occur when hair follicles become clogged with oil and dead skin cells. The condition can lead to inflammatory lesions such as papules and pustules, as well as non-inflammatory lesions like open and closed comedones. Acne vulgaris often begins during puberty due to hormonal changes but can persist into adulthood. The severity of acne can vary, with some individuals experiencing mild outbreaks and others having more severe and persistent forms. The progression of acne can be influenced by factors such as genetics, diet, and stress.

Trial ID:

2024-518430-91-00

Protocol code:

CLITRET/VER

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness of Clindamycin and Tretinoin Gel for Treating Acne in Patients

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