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Acne Vulgaris clinical trials

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NCT ID: NCT06454708 Not yet recruiting - Acne Vulgaris Clinical Trials

Pharmacokinetics, Safety and Tolerability of Clascoterone Cream 1% in Healthy Chinese Adult Subjects

Start date: July 2024
Phase: Phase 1
Study type: Interventional

The primary objective of this study is to determine the pharmacokinetics (PK) of Clascoterone Cream, 1% after single dose and repeat dose topical administrations in healthy Chinese adult subjects.

NCT ID: NCT06447480 Not yet recruiting - Acne Vulgaris Clinical Trials

Randomized Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients

ETHNIC
Start date: September 1, 2024
Phase: Phase 3
Study type: Interventional

In Dermatology, assessment of people of color remains underrepresented in RCTs (<10%) and guidelines. Acne affects around 9% of the population worldwide and negatively affects quality of life and self-esteem with anxiety, suicidal ideation and physical scarring. Main lesions associate comedons, inflammatory papules and pustules which grading of severity allows decision-making, e.g., topicals in mild acne and isotretinoin in severe acne. In darker skin type patients, i.e., Fitzpatrick phototypes IV-VI, acne-related pigmentation (ARP) occurs in 65% of cases which reflects either per- or post-inflammatory hyperpigmentation. Whatever is the mechanism, ARP (number, size, importance of dyschromia) impacts the quality of life in such patients. In moderate acne, treatment is based on oral antibiotics for 3 months, i.e., doxycycline or lymecycline, with topical treatment like tretinoin targeting comedons (and potentially ARP). However, oral antibiotics first-line were developed in white skin patients only and never showed its efficacy in ARP. Moreover, doxycycline could be associated with new-onset hyperpigmentation in acne patients. Isotretinoin -acting on the sebaceous gland and therefore the most effective drug in acne- is only prescribed after failure of antibiotics according to the guidelines.The main objective: To assess the superiority at M6 of a treatment of moderate facial acne in skin of color patients with oral isotretinoin in first line compared to the current standard of care on the severity of ARP.Multicenter randomized controlled trial - open study. The number of subjects required for the trial = 420

NCT ID: NCT06425900 Not yet recruiting - Acne Vulgaris Clinical Trials

A Study to Assess Sebaceous Gland Changes and Constituents of Sebum (Skin Oil) Induced by Clascoterone 1% Cream in Acne Patients

Start date: July 2024
Phase: Phase 4
Study type: Interventional

to compare facial sebaceous gland morphology after 3 months of clascoterone cream 1% treatment and to compare facial sebum constituents at baseline to facial sebum constituents after 3 months of clascoterone cream 1% treatment

NCT ID: NCT06362889 Not yet recruiting - Clinical trials for Acne Vulgaris (Disorder)

Evaluating Microneedling With CBD and Hempseed Oil for Acne Vulgaris Safety and Efficacy

Start date: May 2024
Phase: Phase 1
Study type: Interventional

This is a prospective, single center, open label study to assess the safety and effectiveness of microneedling with CBD and hempseed oil for the treatment of moderate to severe acne in adults 22-years of age or older.The objective of this exploratory study is to evaluate the safety and efficacy of HealMD's CBD with hempseed oil to reduce the appearance of moderate to severe facial acne.

NCT ID: NCT06340984 Not yet recruiting - Acne Vulgaris Clinical Trials

Serum Intercellular Adhesion Molecule -1 in Acne Vulgaris Patients : Effect of Montelukast

Start date: June 2024
Phase: Phase 3
Study type: Interventional

The aim of this study is to: 1. Evaluation of serum soluble intercellular adhesion molecule-1 (sICAM-1) level in acne vulgaris and compare it to control group 2. Evaluate its role in acne pathogenesis and its correlation with acne vulgaris severity 3. Evaluate the effect of Montelukast on serum (sICAM-1) level in acne vulgaris

NCT ID: NCT06248008 Not yet recruiting - Acne Clinical Trials

A Study to Evaluate Safety of ASC40 Tablets in Patients With Moderate to Severe Acne Vulgaris

Start date: April 24, 2024
Phase: Phase 3
Study type: Interventional

This is a multicenter, open-label study designed to determine the long-term safety of ASC40 (Denifanstat) tablets in patients with moderate to severe acne vulgaris enrolled in the ASC40-303 Phase III study. All subjects are eligible for study eligibility screening after enrollment in ASC40-303 Phase III study, and all eligible subjects with moderate to severe acne vulgaris will receive ASC40 (Denifanstat) tablets after signing informed consent. The investigational drug will be administered orally once daily (QD) for up to 40 weeks. There will be a total of 7 visits for screening and follow-up. The tests required by the program included routine blood tests, blood biochemistry, lipid profile, pregnancy test and urine routine, etc.

NCT ID: NCT06237387 Not yet recruiting - Acne Vulgaris Clinical Trials

Association of Acne Vulgaris With Oral Hygiene and Gingivitis

Start date: June 5, 2024
Phase:
Study type: Observational

The goal of this observational study is to learn about in the relationship between acne vulgaris and oral hygiene and gingivitis. The main questions it aims to answer are: - Is there a relationship between the severity of acne vulgaris lesions and the severity of plaque-related gingivitis? - Could oral hygiene or the severity of plaque-related gingivitis have an impact on the treatment of acne lesions? Participants will; - First be examined at the dermatology clinic. - Then be examined at the periodontology clinic. - Participants with severe acne vulgaris lesions will be examined a second time at the dermatology clinic. (1.5 months after the first examination) - Regularly use the antibiotic containing 100 mg doxycycline prescribed in the dermatology clinic for acne treatment. (Patients deemed suitable by the dermatologist)

NCT ID: NCT06225570 Not yet recruiting - Acne Vulgaris Clinical Trials

Weekly Isotretinoin vs Tetracycline for Moderate Acne

Start date: January 2025
Phase: Early Phase 1
Study type: Interventional

In the effort to find better treatments for Moderate Acne, which often relies on long-term antibiotic use, researchers are exploring alternative options. While Isotretinoin, a Vitamin A derivative, is highly effective for severe acne, its side effects limit its use for milder cases. A recent study from our institution investigated a new approach: weekly Isotretinoin dosing. The results were promising, with acne improvement and no major side effects. This suggests that weekly Isotretinoin could be a successful alternative for moderate acne in both males and females. To validate these findings, investigators propose a randomized controlled trial comparing weekly Isotretinoin to daily Doxycycline over four months. This study could confirm the safety and effectiveness of weekly Isotretinoin, as well as shed light on patient satisfaction, and long-term results compared to standard antibiotics. This research may offer a breakthrough in treating moderate acne while addressing concerns about antibiotic overuse.

NCT ID: NCT06175819 Not yet recruiting - Acne Vulgaris Clinical Trials

Efficacy of Manuka Honey Nano-Formulation in the Treatment of Acne Vulgaris

Start date: January 2024
Phase: N/A
Study type: Interventional

The present study aims to manufacture manuka honey-loaded nano-formulation using natural materials as a potent tissue-healing remedy and compare it to commercially available antimicrobial therapy in order to reduce the severity and recurrences of skin lesions.

NCT ID: NCT06158061 Not yet recruiting - Acne Vulgaris Clinical Trials

Assessment of Serum and Tissue Tryptase Levels in Acne Vulgaris Patients

Start date: January 24, 2024
Phase: N/A
Study type: Interventional

Acne vulgaris is an inflammatory disorder of pilosebaceous glands. Acne is a highly prevalent inflammatory disease affecting approximately 9.4% of the world's population , and estimated up to 90% among adolescents. By natural course acne starts at 7-12 ages and mostly resolves by the third decade of individuals life . Mast cells may play important role in maintenance of physiological functions of our body; they also have a role in pathological and inflammatory mechanisms of many diseases. Tryptase is suggested to be important for survival as no tryptase-deficient human subject has yet been reported. Tryptase is mainly synthesized by mast cells but a very low amount may originate in basophil with no interference with total levels of the enzyme. Tryptase is currently considered as a metabolic signaling and effector mediator for acute mast cell degranulation and late phase of allergy and inflammation .