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

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ClinicalTrials.gov Identifier: NCT03626298
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Irma Bernadette S Sitohang, 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.

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

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Study Type : Interventional  (Clinical Trial)
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 : August 1, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. inflammatory and non-inflammatory acne lesion reduction number analyzed using GLMM [ Time Frame: 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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:

-


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Responsible Party: Dr Irma Bernadette S Sitohang, Medical Doctor, Rumah Sakit Pusat Angkatan Darat Gatot Soebroto
ClinicalTrials.gov Identifier: NCT03626298     History of Changes
Other Study ID Numbers: PapulexPaper1
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Adapalene
Niacinamide
Niacin
Nicotinic Acids
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Vitamin B Complex
Vitamins
Micronutrients
Nutrients
Growth Substances
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents