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

R

Rumah Sakit Pusat Angkatan Darat Gatot Soebroto

Status and phase

Completed
Phase 4

Conditions

Acne Vulgaris

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03626298
PapulexPaper1

Details and patient eligibility

About

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.

Enrollment

125 patients

Sex

All

Ages

12 to 50 years old

Volunteers

Accepts 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

-

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

125 participants in 2 patient groups, including a placebo group

Adapalene and placebo (ADAP)
Placebo Comparator group
Treatment:
Drug: Placebos
Drug: Adapalene
Adapalene, Nicotinamide, ABA, Zinc PCA (ANAZ)
Experimental group
Treatment:
Drug: Nicotinamide, ABA and Zinc PCA
Drug: Adapalene

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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