The Effectiveness and Safety of Cleanser Containing Triethyl Citrate, Pyruvic Acid, Combination Cream Containing Triethyl Citrate, Ethyl Linoleate, GT Peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic Acid and Spot Cream Containing Triethyl Citrate, Ethyl Linoleate, GT Peptide-10, Honokiol

Официальное название

The Effectiveness and Safety of Cleanser Containing Triethyl Citrate, Pyruvic Acid, Combination Cream Containing Triethyl Citrate, Ethyl Linoleate, GT Peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic Acid and Spot Cream Containing Triethyl Citrate, Ethyl Linoleate, GT Peptide-10, Honokiol As Adjuvant Therapy for Mild to Moderate Acne Vulgaris

Обзор

The goal of this clinical study is to learn the effectiveness and safety of Cleanser containing Triethyl citrate, Pyruvic acid, Combination cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic acid 0,5%, Zinc lactate, Hyaluronic acid and Spot cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol as Adjuvant Therapy for Mild to Moderate Acne Vulgaris. This research aims to answer the main questions, those are : 1. How is the effectiveness of Cleanser containing Triethyl citrate, Pyruvic acid, Combination cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic acid 0,5%, Zinc lactate, Hyaluronic acid and Spot cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol as Adjuvant Therapy for Mild to Moderate Acne Vulgaris? 2. How is the safety of Cleanser containing Triethyl citrate, Pyruvic acid, Combination cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic acid 0,5%, Zinc lactate, Hyaluronic acid and Spot cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol as Adjuvant Therapy for Mild to Moderate Acne Vulgaris? Participants are males and females between 15-50 years old. Participants will be examined by dermatologist, and will be photographed in five different positions, and also evaluated by janus facial analysis system. The participants are asked to use Cleanser containing Triethyl citrate, Pyruvic acid, Combination cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic acid 0,5%, Zinc lactate, Hyaluronic acid and Spot cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol as Adjuvant Therapy. The participants will be evaluated in 28, 56 and 84 days after the treatment.

Подробное описание

This study is a clinical study with randomized controlled trial design to learn the effectiveness and safety of Cleanser containing Triethyl citrate, Pyruvic acid, Combination cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic acid 0,5%, Zinc lactate, Hyaluronic acid and Spot cream containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol as Adjuvant Therapy for Mild to Moderate Acne Vulgaris. This study will be conducted in three Dermatology and Venereology Education Centers in Indonesia located in Jakarta (Rumah Sakit Pusat Angkatan Darat Gatot Soebroto), Padang (Rumah Sakit Umum Pusat Dr. M. Djamil), Bali (Rumah Sakit Umum Pusat Prof. Dr. I.G.N.G Ngoerah). Group 1 will receive placebo cleanser, placebo combination cream, and placebo spot cream every morning and evening, and then placebo cleanser, placebo combination cream and adapalene 0,1% every night. Group 2 will receive cleanser, containing Triethyl citrate, Pyruvic acid, combination cream, containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic acid, and spot cream, containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol, every morning and evening, and then cleanser, containing Triethyl citrate, Pyruvic acid, combination cream, containing Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic acid, and adapalene 0,1% cream every night. All participant will be evaluated in day 28, 56, and 84. Therapy evaluation will be assessed by dermatologist based on the Global Acne Severity Scale (GEA Score), Indonesia Acne Expert Meeting (IAEM Score), Clinician Erythema Assessment (CEA), Total of Inflammation and Non-Inflammation lesions, Acne Sequelae, facial skin analysis with Janus Skin Facial Analysis, and evaluation of quality of life using Acne-Quality of Life (Acne-QoL).

Вмешательства

• Препарат Cleanser
  Cleanser consist of Triethyl citrate and Pyruvic acid, will be given to subjects to be applied every morning, evening and night in group 2
• Препарат Combination cream
  combination cream consist of Triethyl citrate, Ethyl linoleate, GT peptide-10, Salicylic Acid 0,5%, Zinc Lactate, Hyaluronic acid will be given to subjects to be applied every morning, evening and night in group 2
• Препарат spot cream
  spot cream consist of Triethyl citrate, Ethyl linoleate, GT peptide-10, Honokiol, will be given to subjects to be applied every morning and evening in group 2
• Препарат Adapalene 0,1% cream
  adapalene 0.1% cream will be given to subjects to be applied every night in group 1 and 2
• Препарат placebo cleanser
  placebo cleanser will be given to subjects to be applied every morning, evening and night in group 1
• Препарат placebo cream combination
  placebo cream combination will be given to subjects to be applied every morning, evening and night in group 1
• Препарат placebo spot cream
  placebo spot cream will be given to subjects to be applied every morning and evening in group 1

Первичные конечные точки

• Change of acne severity [Срок оценки: Re-evaluation on day 28, 56 and 84 of therapy]
• Change of acne severity [Срок оценки: Re-evaluation on day 28, 56 and 84 of therapy]
• total of inflammation lesion and non inflammation lesion [Срок оценки: Re-evaluation on day 28, 56 and 84 of therapy]
• acne sequelae [Срок оценки: Re-evaluation on day 28, 56 and 84 of therapy]
• Quality of life [Срок оценки: Re-evaluation on day 28, 56 and 84 of therapy]
• Erythema severity [Срок оценки: Re-evaluation on day 28, 56 and 84 of therapy]
• Facial analysis [Срок оценки: Re-evaluation on day 28, 56 and 84 of therapy]

Критерии участия

Критерии включения

• Female and male aged 15-50 years
• mild to moderate acne vulgaris according to IAEM (Indonesian Acne Expert Meeting) scale and GEA ( Global Acne Severity) scale
• The subject is willing to participate in the study until it is finished

Критерии исключения

• History of allergy to dermocosmetic products
• Undergoing other acne therapy, medication, or invasive action in the last month
• Pregnant or breastfeeding subjects

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• Rumah Sakit Pusat Angkatan Darat Gatot Soebroto — Jakarta

Идентификаторы

NCT: NCT06775314 · AKNICARE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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