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

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Status and phase: Completed; Phase 4

Conditions: Acne Vulgaris

Treatments: Drug: Adapalene; Drug: Placebos; Drug: Nicotinamide, ABA and Zinc PCA

Study type: Interventional

Funder types: Other

Identifiers

NCT03626298

PapulexPaper1

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 12 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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125 participants in 2 patient groups, including a placebo group

Adapalene and placebo (ADAP)

Placebo Comparator group

Treatment:

Drug: Placebos

Drug: Adapalene

Adapalene, Nicotinamide, ABA, Zinc PCA (ANAZ)

Experimental group

Treatment:

Drug: Nicotinamide, ABA and Zinc PCA

Drug: Adapalene