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

Sponsor

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto (Other)

Overall Status

Completed

CT.gov ID

NCT03626298

Collaborator

(none)

125

Enrollment

Arms

20.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Adapalene Drug: Nicotinamide, ABA and Zinc PCA Drug: Placebos	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

125 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Dec 31, 2016

Actual Study Completion Date :

Apr 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Adapalene and placebo (ADAP)	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: 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.
Experimental: Adapalene, Nicotinamide, ABA, Zinc PCA (ANAZ)	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

Arm

Intervention/Treatment

Placebo Comparator: Adapalene and placebo (ADAP)

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: 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.

Experimental: Adapalene, Nicotinamide, ABA, Zinc PCA (ANAZ)

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

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Irma Bernadette S Sitohang, Medical Doctor, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

ClinicalTrials.gov Identifier:

NCT03626298

Other Study ID Numbers:

PapulexPaper1

First Posted:

Aug 13, 2018

Last Update Posted:

Aug 13, 2018

Last Verified:

Aug 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 13, 2018