Skip to main content
OpenTrials
Completed

NCT Number: NCT00838812

Safety and Efficacy Study of Association Between Tretinoin and Clindamycin on the Treatment of Acne Mild and Moderate

The purpose of this study is to determine the safety and efficacy of association between tretinoin and clindamycin phosphate on the treatment of acne vulgaris mild and moderate.

Completed

Looking for future studies?

Notify Me

Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Lal Clinica

Valinhos, São Paulo, 13276-245, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals of both sexes with age greater than or equal to 12 years
  • Subjects diagnosed with acne vulgaris in the face, except for the nasal area, range from mild to moderate, with the following requirements.
  • Mild acne = presence of fewer than 20 comedones or less than 15 lesions, inflammatory lesions or a total of less than 30 injuries.
  • Moderate acne = presence of 20 the 100 comedones or of 15 the 50 inflamatory lesions or a total of 30 the 125 lesions, with not more than lesions small nodule until 5,0 mm.
  • Ensure that the existing injuries were not submitted any treatment for acne, topical or systemic, within the last 30 days.
  • Be able to properly follow the determinations of the Protocol.
  • Has provided a written voluntary consent to participate in the study, by signing the informed consent, before being subjected to any procedure.
  • Under 18 years old, be accompanied by legal guardian in the process of obtaining the informed consent.
  • Be mentally able to provide consent and be fulfilling all the requirements of the study.

Exclusion criteria

  • Pregnant women or in periods of lactation.
  • Women of childbearing age and sexual activity with not using safe contraceptive method, such as oral contraceptives, implantable, injectable or intra-uterine, introduced for at least 120 days.
  • Women who are using oral contraceptives containing the hormone combination for acetate ciprosterone and etinolestradiol, association of drospirenone and ethinyl estradiol, or desogestrel.
  • Clinical evidence or history of immunodeficiency.
  • Any use of immunosuppressive drug and/or immunomodulating over the past 3 months, topical or systemic.
  • Concurrent use of fotossentetizadores, neuromuscular blockers, medications that exacerbate the acne, blockers (filters) with solar alcoholic vehicle, spironolactone, flutamide or zinc salts.
  • Prior use of systemic retinoid.
  • Presence of acne medication and/or cosmetic.
  • History of systemic metabolic disorder that can interfere with the integrity of the skin.
  • History of inflammatory disease, intestinal or regional enteritis and/or symptoms similar.
  • History of joy to any of the components of the formula (active principle or carrier).
  • History of abuse of alcohol and/or illegal drugs.
  • History of non-adherence to medical treatment earlier.
  • Any clinical observation made by the investigator that prohibits participation in the study of the subject.

Treatment and study plan

application of the topic gel

Drug

Clindamycin Phosphate 1,2% and tretinoin 0,025% gel once daily at night 12 weeks.

Primary outcomes

  1. Evaluation of the efficacy, through number of lesions, and tolerability of the product.

    Time frame: three months

Sponsors and collaborators

Lead sponsor

Igefarma Laboratorios S.A.

Industry

Registry information

Official study title

Monocentric Study, Prospective, Open and Non Controlled for to Evaluate the Effectiveness, and Tolerability the Safety of Association of Clindamycin Phosphate 1.2% and Tretinoin 0,025% in the Treatment of Acne Vulgaris Mild to Moderate, When Used Once Daily for 12 Weeks.

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 6, 2009
Registry last updated
May 25, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.