Study on the Effectiveness and Safety of Clindamycin and Tretinoin Gel for Patients with Papulopustular Acne

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment for papulopustular acne, a common skin condition characterized by red, inflamed bumps and pimples. The study will compare the effectiveness and safety of a new gel containing Clindamycin and Tretinoin against an existing treatment called Acnatac and a placebo. Clindamycin is an antibiotic that helps reduce bacteria and inflammation, while Tretinoin is a form of vitamin A that helps the skin renew itself more quickly.

The purpose of the study is to determine how well the new gel works in reducing the number of acne lesions over a period of 12 weeks. Participants will be randomly assigned to use either the new gel, the existing treatment, or a placebo. The study will involve regular visits to monitor the skin’s response to the treatment and to ensure the safety of all participants. The treatment will be applied to the skin, and the progress will be assessed by counting the number of acne lesions at different points during the study.

Throughout the study, both the participants and the researchers will not know which treatment each participant is receiving, which is known as a “double-blind” study. This helps ensure that the results are not biased. The study aims to provide valuable information on the potential benefits of the new gel in treating papulopustular acne and to compare its effectiveness with the existing treatment and a placebo. Participants will be closely monitored for any side effects or changes in their skin condition during the study period.

1 joining the study

Upon joining the study, the patient will be informed about the trial and will provide written consent to participate. If the patient is under 18, consent from a legal guardian is also required.

2 initial assessment

The patient will undergo an initial assessment to confirm the diagnosis of papulopustular acne. This includes having at least 25 non-inflammatory lesions and 20 inflammatory lesions on the face, with no more than 2 nodular lesions.

3 treatment allocation

The patient will be randomly assigned to one of three groups: Clindamycin/Tretinoin Gel (10 mg/g + 0.25 mg/g), Acnatac Gel (10 mg/g + 0.25 mg/g), or a vehicle gel. The treatment is applied to the skin.

4 treatment administration

The patient will apply the assigned gel to the affected areas of the skin as directed. The frequency and duration of application will be specified by the study protocol.

5 follow-up visits

The patient will attend regular follow-up visits to monitor progress. These visits will occur at specified intervals, including baseline (Visit 1) and subsequent visits (Visit 2 to Visit 8).

6 evaluation of results

The primary goal is to assess the change in the number of inflammatory and total lesions from the start of the study to week 12. Secondary evaluations include changes in non-inflammatory lesions and overall therapeutic success.

7 completion of the study

At the end of the study, the patient will have a final assessment to evaluate the overall effectiveness and safety of the treatment. The study is expected to conclude by May 2026.

Who Can Join the Study?

Women, men, and adolescents aged between 12 and 65 years can participate.
Participants must provide written consent to join the study after being informed by the study investigator.
If the participant is under 18, both the legal guardian(s) and the adolescent must provide written consent after being informed in a way suitable for their age.
Participants must have a diagnosis of papulopustular acne, which is a type of acne with red bumps and pus-filled spots, based on commonly accepted criteria.
On the face, participants must have at least 25 non-inflammatory lesions (like blackheads and whiteheads) and at least 20 inflammatory lesions (such as red bumps and pus-filled spots), with no more than 2 nodular lesions (larger, deeper bumps).
The severity of acne must be assessed by the investigator as grade 2, 3, or 4 on the Investigator’s Global Assessment (IGA) scale, which is a way to measure how severe the acne is.
Women who can become pregnant must use a highly effective method of birth control throughout the study.
All female participants who can become pregnant must have a urine pregnancy test with a negative result before starting the study. The test must be sensitive enough to detect low levels of a pregnancy hormone called human chorionic gonadotrophin (hCG).

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Praxis Dr. med. Abdou Zarzour	Halle (Saale)	Germany
Gemeinschaftspraxis Drs. Josef und Wilma Großkopf	Wallerfing	Germany
Studienzentrum Dr. Beate Schwarz	Langenau	Germany
Praxis Geseke	Geseke	Germany

Other Sites

Site Name	City	Country
CentroDerm GmbH	Wuppertal	Germany
ProDerma	Duelmen	Germany
Pvhsxl Faga Dmukfcbtbmar Ulz Vgjifztjvir	Dresden	Germany
Mqqohcoxajc Cfrphss Fmm Mymlkra Sqphmmp &ixtu Scvcqjlm Glcb	Magdeburg	Germany
Hcuxgxwzslemzt Dkb Olzfrh ulg Dwn Aojhxjz	Ibbenbüren	Germany
Dvmuy Sxussnp Gkvp	Hamburg	Germany
Hemj Hmzly uls Lahgsblapwfy Pmpuvkk	Potsdam	Germany
Hygkeltifiswxpx	Hamm	Germany
Pqkrzs Dsh Jhxmp Rgppter	Berlin	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	06.05.2024

Trial locations

Investigated drugs:

Clindamycin/Tretinoin Gel is a combination medication used in this study to treat papulopustular acne. Clindamycin is an antibiotic that helps reduce the bacteria that cause acne, while Tretinoin is a form of vitamin A that helps the skin renew itself more quickly. This gel is being tested for its effectiveness in reducing acne lesions.

Acnatac Gel is another combination medication used as a reference in this study. It contains the same active ingredients as the test gel, Clindamycin and Tretinoin, and is already used to treat acne. The study aims to compare its effectiveness and safety against the test gel.

Papulopustular acne – This is a common skin condition characterized by the presence of papules and pustules, which are types of inflamed blemishes. Papules are small, raised, red bumps that can be tender, while pustules are similar but contain pus. The condition typically affects areas of the skin with a high density of oil glands, such as the face, back, and shoulders. It often begins during puberty due to hormonal changes that increase oil production in the skin. The excess oil, along with dead skin cells, can clog pores and lead to bacterial growth, resulting in inflammation. Over time, the severity of the acne can fluctuate, with periods of improvement and worsening.

Trial ID:

2023-504552-10-01

Protocol code:

23-01/ClindaTret-G

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Clindamycin and Tretinoin Gel for Patients with Papulopustular Acne

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