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Clinical Trials/NCT03585140
NCT03585140
Completed
Not Applicable

Effect of Adding a Diet With Low Glycemic Index and Load During 12 Weeks for the Treatment of Moderate Acne in Adults: a Randomized Clinical Trial

Centro Dermatológico Dr. Ladislao de la Pascua0 sites52 target enrollmentJanuary 1, 2016

Overview

Phase
Not Applicable
Intervention
Normal diet
Conditions
Acne Vulgaris
Sponsor
Centro Dermatológico Dr. Ladislao de la Pascua
Enrollment
52
Primary Endpoint
Count of inflammatory acne lesions
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

Clinical trial to determine the effect of adding a diet with low glycemic index and load to adults for the treatment of moderate acne. Adult patients with acne where recruited in two groups, A and B. Group A received a normal diet according to their metabolic status and group B received a diet with low glycemic index and load. Outcomes were measured at week 12.

Detailed Description

Clinical trial to determine the effect of adding a diet with low glycemic index and load to adults for the treatment of moderate acne. Adult patients with acne where recruited in two groups, A and B. Both groups of treatment were treated with doxycycline 100 mg per day plus adapalene 0.1% gel daily for 12 weeks. During pharmacologic treatment, all patients had nutrition counseling monthly. Group A received a normal diet according to their metabolic status and group B received a diet with low glycemic index and load. At the end of the trial, the change in acne lesions count was analyzed and also their metabolic status. Quality of life was also measured.

Registry
clinicaltrials.gov
Start Date
January 1, 2016
End Date
November 30, 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Centro Dermatológico Dr. Ladislao de la Pascua
Responsible Party
Principal Investigator
Principal Investigator

Dra. Martha Alejandra Morales Sánchez

MD

Centro Dermatológico Dr. Ladislao de la Pascua

Eligibility Criteria

Inclusion Criteria

  • Having moderate inflammatory acne
  • 18 to 25 years old
  • Stable weight during the last 3 months

Exclusion Criteria

  • Previous or actual isotretinoin therapy
  • Antibiotic therapy or during the last 3 months
  • Therapy based on peelings, dermabrasion, laser or intense pulsed light during the last 6 months
  • Endocrine disorders
  • Drug and alcohol consumption during the last 6 months
  • Tabacco use during the last 6 months
  • Lactose intolerance
  • Have eating disorders or gastrointestinal disorders
  • Actual nutrition therapy
  • Have chronic diseases that requires pharmacologic therapy

Arms & Interventions

Normal Diet

Participants will receive a normal diet according to their metabolic status.

Intervention: Normal diet

Normal Diet

Participants will receive a normal diet according to their metabolic status.

Intervention: Adapalene 0.1% Gel

Normal Diet

Participants will receive a normal diet according to their metabolic status.

Intervention: Doxycycline

Low glycemic diet

Participants will receive a low-glycemic index and load diet according to their metabolic status. Milk and vitamin supplements will be eliminated from the diet.

Intervention: Low glycemic diet

Low glycemic diet

Participants will receive a low-glycemic index and load diet according to their metabolic status. Milk and vitamin supplements will be eliminated from the diet.

Intervention: Adapalene 0.1% Gel

Low glycemic diet

Participants will receive a low-glycemic index and load diet according to their metabolic status. Milk and vitamin supplements will be eliminated from the diet.

Intervention: Doxycycline

Outcomes

Primary Outcomes

Count of inflammatory acne lesions

Time Frame: 12 weeks

Number of papules and pustules

Secondary Outcomes

  • Count of non-inflammatory acne lesions(12 weeks)
  • Changes in quality of life(12 weeks)

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