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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Adapalene
Nicotinamide, ABA and Zinc PCA
Placebos
Sponsored by
Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 50 Years (Child, Adult)All SexesAccepts 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:

-

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Adapalene and placebo (ADAP)

    Adapalene, Nicotinamide, ABA, Zinc PCA (ANAZ)

    Arm Description

    Outcomes

    Primary Outcome Measures

    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)

    Secondary Outcome Measures

    Full Information

    First Posted
    July 17, 2018
    Last Updated
    August 7, 2018
    Sponsor
    Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03626298
    Brief Title
    Efficacy and Tolerability of Nicotinamide Plus Cream for Moderate Acne Vulgaris in Indonesia
    Official Title
    Efficacy and Tolerability of Nicotinamide Plus Cream for Moderate Acne Vulgaris in Indonesia: A Multicenter Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 1, 2016 (Actual)
    Primary Completion Date
    December 31, 2016 (Actual)
    Study Completion Date
    April 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acne Vulgaris

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    125 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Adapalene and placebo (ADAP)
    Arm Type
    Placebo Comparator
    Arm Title
    Adapalene, Nicotinamide, ABA, Zinc PCA (ANAZ)
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Adapalene
    Intervention Description
    third-generation topical retinoid primarily used in the treatment of mild-moderate acne. It is effective against acne conditions where comedones are predominant.
    Intervention Type
    Drug
    Intervention Name(s)
    Nicotinamide, ABA and Zinc PCA
    Intervention Description
    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
    Intervention Type
    Drug
    Intervention Name(s)
    Placebos
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    inflammatory and non-inflammatory acne lesion reduction number analyzed using GLMM
    Description
    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)
    Time Frame
    6 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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: -

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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