Efficacy and Tolerability of Nicotinamide Plus Cream for Moderate Acne Vulgaris in Indonesia

Study Overview
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Brief Summary
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Acne vulgaris (AV) is a chronic inflammatory disease of the pilosebaceous unit that affects seborrheic areas such as the face, back and chest. AV is characterized by blackheads, papules, pustules nodes and cysts with sequelae of hyperpigmentation and scarring. It is one of the most common skin disorders treated by dermatologists. Acne vulgaris can be found at any age, although it is more frequent in teenagers and young adults. The prevalence of AV in a population of 11 to 30 years old is approximately 80%. Due to its involvement of the face, it is considered to be a cosmetic problem, thus bearing a psychosocial burden.

Official Title
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Efficacy and Tolerability of Nicotinamide Plus Cream for Moderate Acne Vulgaris in Indonesia: A Multicenter Clinical Trial

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Adapalene
* Drug: Nicotinamide, ABA and Zinc PCA
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: moderate acne vulgaris 12 and up to 50 years old, agreed to become research participants and has signed the informed consent. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Adapalene and placebo (ADAP)<br> | Drug: Adapalene<br>* third-generation topical retinoid primarily used in the treatment of mild-moderate acne. It is effective against acne conditions where comedones are predominant.<br>Drug: Placebos<br>* Placebo cream. to resemble an active medication or therapy so that it functions as a control; this is to prevent the recipient(s) and/or others from knowing (with their consent) whether a treatment is active or inactive, as expectations about efficacy can influence results.<br>|
| Experimental: Adapalene, Nicotinamide, ABA, Zinc PCA (ANAZ)<br> | Drug: Adapalene<br>* third-generation topical retinoid primarily used in the treatment of mild-moderate acne. It is effective against acne conditions where comedones are predominant.<br>Drug: Nicotinamide, ABA and Zinc PCA<br>* combination of three non-antibiotic active ingredients of nicotinamide, anti-bacterial adhesive agent (ABA) and zinc, or abbreviated as ANAZ to be well-tolerated by patients with acne vulgaris<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory and non-inflammatory acne lesion reduction number analyzed using GLMM | objective evaluation was based on photographs of participants from three angles per visit. The outcome of efficacy was measured from the percentage reduction of inflammatory and non-inflammatory lesions number and analyzed using the GLMM (General Linear mixed Model) | 6 weeks |