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

Phase 4

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Adapalene; Drug: Nicotinamide, ABA and Zinc PCA; Drug: Placebos

• Registration Number: NCT03626298
• Lead Sponsor: Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-01
• Primary Completion: 2016-12-31
• Study Completion: 2018-04-30
• Study First Submitted: 2018-07-17
• Status Verified: 2018-08
• Study First Submitted QC: 2018-08-07
• Last Update Submitted: 2018-08-07
• Study First Posted: 2018-08-13
• Last Update Posted: 2018-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adapalene, Nicotinamide, ABA, Zinc PCA (ANAZ)	Nicotinamide, ABA and Zinc PCA	-
Adapalene and placebo (ADAP)	Placebos	-
Adapalene and placebo (ADAP)	Adapalene	-
Adapalene, Nicotinamide, ABA, Zinc PCA (ANAZ)	Adapalene	-

Primary Outcome Measures

Name	Time	Method
inflammatory and non-inflammatory acne lesion reduction number analyzed using GLMM	6 weeks	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)