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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-01

Study Completion Date

2018-04-30

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.

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Detailed Description

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Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Adapalene and placebo (ADAP)

Group Type PLACEBO_COMPARATOR

Adapalene

Intervention Type DRUG

third-generation topical retinoid primarily used in the treatment of mild-moderate acne. It is effective against acne conditions where comedones are predominant.

Placebos

Intervention Type DRUG

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.

Adapalene, Nicotinamide, ABA, Zinc PCA (ANAZ)

Group Type EXPERIMENTAL

Adapalene

Intervention Type DRUG

third-generation topical retinoid primarily used in the treatment of mild-moderate acne. It is effective against acne conditions where comedones are predominant.

Nicotinamide, ABA and Zinc PCA

Intervention Type DRUG

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

Interventions

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Adapalene

third-generation topical retinoid primarily used in the treatment of mild-moderate acne. It is effective against acne conditions where comedones are predominant.

Intervention Type DRUG

Nicotinamide, ABA and Zinc PCA

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

Intervention Type DRUG

Placebos

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.

Intervention Type DRUG