Effectivity and Safety of Combination Cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad and Zinc PCA

Acne Vulgaris Clinical Trial

Official title:

Effectivity and Safety of Combination Cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad and Zinc PCA as Adjuvant Therapy for Acne Vulgaris Mild to Moderate

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05497323
• Other study ID #: EffectivityCombiAquaPosae
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 1, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: April 2023
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical study will compare the effectivity and safety of combination cream of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad, and Zinc PCA as adjuvant therapy for acne vulgaris patients. These combination cream will be tested by mild to moderate acne vulgaris patients. Participants will be female patients aged 15-50 years old and divided into three groups. The control group (Group 1) will use Adapalene 0.1% cream only every night. Group 2 will use Adapalene 0.1% cream intermittently every two nights and the combination cream every morning. Group 3 will use Adapalene 0.1% cream every night and the combination cream every morning.

Description:

This study is an experimental study with a randomized controlled trial (RCT) design on mild to moderate acne vulgaris patients who met the inclusion criteria. This study will be conducted in five Dermatology and Venereology Education Centers in Indonesia located in Jakarta (Rumah Sakit Umum Pusat Nasional dr. Cipto Mangunkusumo), Jakarta (Rumah Sakit Pusat Angkatan Darat Gatot Soebroto), Padang (Rumah Sakit Umum Pusat Dr. M. Djamil), Surakarta (Rumah Sakit Umum Daerah Dr. Moewardi), and Malang (Rumah Sakit Umum Daerah Dr. Saiful Anwar). Group 1 as control group, will receive Adapalene 0.1% cream only every night. Group 2 will receive Adapalene 0.1% cream only intermittently every two nights, and the combination cream every morning. Group 3 will use Adapalene 0.1% cream every night and the combination cream every morning. All participants will be evaluated in day 28 and 56. Therapy evaluation will be assessed based on the Global Acne Severity Scale (GEA Score), Indonesia Acne Expert Meeting (IAEM Score), Level of Seborrhoea, Clinician Erythema Assessment Scale (CEA), facial skin analysis with Janus Skin Facial Analysis, and evaluation of the quality of life using Cardiff Acne Disability Index and Acne-Quality of Life (Acne-QoL) specifically for participants aged older than 18 years old.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 284
• Est. completion date: May 1, 2023
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 50 Years

Eligibility

Inclusion Criteria:

• Female aged 15 - 50 years
• Mild and moderate acne vulgaris according to IAEM and GEA.
• Patients are willing to participate in the study until it is finished.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Combination Cream
The combination cream consists of Salicylic Acid, Aqua Posae Filiformis, Niacinamide, Lipohydroxy Acid, Procerad and Zinc PCA, were applied every morning by group 2 and group 3.
• Adapalene 0,1% cream
Adapalene 0,1 % cream were given to subjects to be applied every night in group 1 and group 3, and intermittently every two nights in group 2.

Locations

Country	Name	City	State
Indonesia	Rumah Sakit Pusat Angkatan Darat Gatot Soebroto	Jakarta	DKI Jakarta
Indonesia	Rumah Sakit Umum Pusat Cipto Mangunkusumo	Jakarta	DKI Jakarta
Indonesia	Rumah Sakit Umum Daerah Saiful Anwar	Malang	Jawa Timur
Indonesia	Rumah Sakit Umum Pusat Dr. M. Djamil	Padang	Sumatera Barat
Indonesia	Rumah Sakit Umum Daerah Dr. Moewardi	Surakarta	Jawa Tengah

Sponsors (1)

Lead Sponsor	Collaborator
Dr.dr.Irma Bernadette, SpKK (K)

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of acne severity	Based on Global Acne Severity Scale (GEA Score). On a scale of 0-5, 0 indicates almost no lesions, while 5 indicates severe acne.	re-evaluation on day 28 and day 56 of therapy
Primary	Change of acne severity	Based on Indonesia Acne Expert Meeting (IAEM score). The scale consists of mild, moderate, and severe.	re-evaluation on day 28 and day 56 of therapy
Primary	Change of Level Of Seborrhea	The level of seborrhea is assessed subjectively by participants on a scale of 0 (minimum level) - 10 (maximum level)	re-evaluation on day 28 and day 56 of therapy
Primary	Change of erythema	Based on Clinician Erythema Assessment Scale (CEA) to assess the degree and extent of erythema. The scale ranges from 0-5; 0 indicates no erythema, while 4 indicates severe erythema.	re-evaluation on day 28 and day 56 of therapy
Primary	Change of quality of life	Assessed using Cardiff Acne Disability Index. Cardiff Acne Disability Index questionnaire is an instrument to measure the quality of life of acne vulgaris patients. This instrument has 5 self-answered questions by the patient (for subjects aged= 18 years).	re-evaluation on day 28 and day 56 of therapy
Primary	Change of quality of life	Assessed using Acne-Quality of Life. Acne-QoL is an instrument consisting of 19 questions divided into 4 categories: self-perception, social relationships, emotional effects, and acne symptoms. The total score of Acne-QoL is 0-114. The higher total score for each category obtained will interpret that the quality of life of acne vulgaris patients is getting better.	re-evaluation on day 28 and day 56 of therapy
Primary	Facial Analysis Examination With Janus Facial Analysis System	Assessed using the Janus Facial Analysis System®. Janus Facial Analysis System will issue data related to the patient's facial condition.	re-evaluation on day 28 and day 56 of therapy