A Phase 3 interventional study of Cleanser and Combination cream in Acne Vulgaris, sponsored by Dr.dr.Irma Bernadette, SpKK (K). Not yet recruiting at 1 site in Indonesia. Open to participants aged 15 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by Dr.dr.Irma Bernadette, SpKK (K) · Phase 3, Interventional, and Treatment
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 :
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.
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).
790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.
This study's planned enrollment of 102 is above the median of 70 across 672 interventional studies indexed under Acne Vulgaris.
Browse Acne Vulgaris studies →Dr.dr.Irma Bernadette, SpKK (K) is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
this arm 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
Drug: Adapalene 0,1% cream · Drug: placebo cleanser · Drug: placebo cream combination · Drug: placebo spot cream
this arm 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
Drug: Cleanser · Drug: Combination cream · Drug: spot cream · Drug: Adapalene 0,1% cream
Cleanser consist of Triethyl citrate and Pyruvic acid, will be given to subjects to be applied every morning, evening and night in group 2
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
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
adapalene 0.1% cream will be given to subjects to be applied every night in group 1 and 2
placebo cleanser will be given to subjects to be applied every morning, evening and night in group 1
placebo cream combination will be given to subjects to be applied every morning, evening and night in group 1
placebo spot cream will be given to subjects to be applied every morning and evening in group 1
Change of acne severity
Based on global acne severity scale (GEA score). On a scale of 0-5, 0 indicates no lesion, while 5 indicates very severy acne
Time frame: Re-evaluation on day 28, 56 and 84 of therapy
Change of acne severity
Based on Indonesia Acne Expert Meeting scale (IAEM scale). the scale consists of mild, moderate and severe.
Time frame: Re-evaluation on day 28, 56 and 84 of therapy
total of inflammation lesion and non inflammation lesion
The total lesion will be examined by dermatologist
Time frame: Re-evaluation on day 28, 56 and 84 of therapy
acne sequelae
The acne sequelae will be examined by dermatologist
Time frame: Re-evaluation on day 28, 56 and 84 of therapy
Quality of life
Based on acne quality of life (Acne-QoL). Total score of acne-QoL is 0-114, the higher score interprets better quality of life of acne vulgaris patient
Time frame: Re-evaluation on day 28, 56 and 84 of therapy
Erythema severity
based on clinician erythema assessment scale (CEA scale). on the scale of 0-4. 0 indicates no erythema, while 4 indicates severe erythema
Time frame: Re-evaluation on day 28, 56 and 84 of therapy
Facial analysis
The facial analysis will be done by using janus facial analysis system
Time frame: Re-evaluation on day 28, 56 and 84 of therapy
Plan to share: Undecided
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This study is not yet recruiting, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Dr.dr.Irma Bernadette, SpKK (K)