NCT03626298

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Rumah Sakit Pusat Angkatan Darat Gatot Soebroto · Academic / Other
• Sex: All
• Age: 12 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Acne Vulgaris

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2016-08-01
• Primary completion: 2016-12-31
• Completion: 2018-04-30
• First posted: 2018-08-13
• Last updated: 2018-08-13