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Study Comparing Acne in Patients Taking Oral Minocycline to Patients Taking Minocycline Plus Topical Tretinoin

D

Derm Research @ 888

Status and phase

Terminated
Phase 4

Conditions

Acne Vulgaris

Treatments

Drug: Minocycline
Drug: Minocycline plus tretinoin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00240513
2004-03

Details and patient eligibility

About

The use of oral antibiotics alone to treat inflammatory acne provides little to no long term therapeutic benefit.

Acne relapse rates can be reduced by using topical tretinoin 0.01% in conjunction with minocycline, thereby increasing the therapeutic effect of the oral antibiotic.

Full description

Although oral antibiotics have been the mainstay of treatment of inflammatory acne for 30 years, studies comparing their efficacy have little scientific value.

Evidence-based dermatology proves minocycline to be an effective treatment for acne vulgaris while the patient remains on the medication; however, the relapse rate of acne after a course of antibiotics has never been established.

The relapse rate would appear to be significant, as repeated courses and long-term antibiotic use are commonly prescribed in practice. The increasing problem of drug resistance has raised issues of the suitability of such long term antibiotic treatment and this overuse is probably a contributing factor of multiple drug resistance in our society.

Enrollment

38 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Provision of written consent
  • Either sex
  • Any age
  • Diagnosis of acne vulgaris with a minimum of 20 inflammatory acne lesions on the face.

Exclusion criteria

  • Known hypersensitivity to tetracyclines
  • Use of any oral antibiotics in the previous 3 months
  • Pregnancy, breast-feeding or lactating
  • Inability or unwillingness to comply with the requirements of the protocol, or agree to the use of their data as determined by the investigator.
  • Concomitant medical condition which, in the investigator's opinion, may confound the study results or interfere with study assessments or outcomes.
  • Patients with severe acne on the chest, back or trunk.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

38 participants in 2 patient groups

Minocycline 3 mo
Active Comparator group
Description:
Minocycline 3 mo
Treatment:
Drug: Minocycline
Minocycline plus Tretinoin
Experimental group
Description:
Minocycline plus Tretinoin for 3 months
Treatment:
Drug: Minocycline plus tretinoin

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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