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

NCT03626298 | Completed Phase 4

• 1 other identifier: PapulexPaper1
• Study Type: interventional
• Target: 125
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Adapalene and placebo (ADAP)

PLACEBO COMPARATOR

Drug: Adapalene; Drug: Placebos

Adapalene, Nicotinamide, ABA, Zinc PCA (ANAZ)

EXPERIMENTAL

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

Interventions

Adapalene DRUG

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

Adapalene and placebo (ADAP); Adapalene, Nicotinamide, ABA, Zinc PCA (ANAZ)

Nicotinamide, ABA and Zinc PCA DRUG

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

Adapalene, Nicotinamide, ABA, Zinc PCA (ANAZ)

Placebos DRUG

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)

Eligibility Criteria

• Age: 12 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• moderate acne vulgaris
• and up to 50 years old,
• agreed to become research participants and has signed the informed consent.

Sponsors & Collaborators

• Rumah Sakit Pusat Angkatan Darat Gatot Soebroto: lead

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Adapalene; Niacinamide

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: August 13, 2018
• Study Start: August 1, 2016
• Primary Completion: December 31, 2016
• Study Completion: April 30, 2018
• Last Updated: August 13, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share