Trial | NCT03626298  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    125
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.
Study Started
Aug 01
2016
Primary Completion
Dec 31
2016
Study Completion
Apr 30
2018
Last Update
Aug 13
2018

Drug Adapalene

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

Drug Nicotinamide, ABA and Zinc PCA [nicotinamide, zinc sulfate]

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

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.

Adapalene and placebo (ADAP) Placebo Comparator

Adapalene, Nicotinamide, ABA, Zinc PCA (ANAZ) Experimental

Criteria 

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:

-
No Results Posted