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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626298
• Other study ID #: PapulexPaper1
• Status: Completed
• Phase: Phase 4
• Start date: August 1, 2016
• Est. completion date: April 30, 2018

Study information

• Verified date: August 2018
• Source: Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: April 30, 2018
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 50 Years

Eligibility

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:

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

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.
• 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
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammatory and non-inflammatory acne lesion reduction number analyzed using GLMM	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)	6 weeks