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Low Glycemic Index and Load Diet for the Treatment of Acne

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ClinicalTrials.gov Identifier: NCT03585140
Recruitment Status : Completed
First Posted : July 12, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Dra. Martha Alejandra Morales Sánchez, Centro Dermatológico Dr. Ladislao de la Pascua

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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Diet Modification Other: Normal diet Other: Low glycemic diet Drug: Adapalene 0.1% Gel Drug: Doxycycline Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial, two-arm
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Diet intervention was made by the nutrition specialist. Neither the principal investigator nor the outcome assessor were aware about the group of diet intervention.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 1, 2016
Actual Primary Completion Date : May 1, 2016
Actual Study Completion Date : November 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne
Drug Information available for: Adapalene

Arm Intervention/treatment
Active Comparator: Normal Diet
Participants will receive a normal diet according to their metabolic status.
Other: Normal diet
The energy consumption of each of the participants will be calculated, using the Mifflin-St Jeor formula. Each participant will receive a standard menu of 6 days according to their metabolic requirements and a list of equivalent foods. The distribution of macronutrients will be: 45% carbohydrates, 30% lipids and 25% proteins.

Drug: Adapalene 0.1% Gel
Adapalene 0.1% gel daily at night for 12 weeks, applied on the face, chest and back.
Other Name: Adapalene

Drug: Doxycycline
Doxycycline 100 mg per day orally, before breakfast

Experimental: 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.
Other: Low glycemic diet
The energy consumption of each of the participants will be calculated, using the Mifflin-St Jeor formula. Each participant will receive a standard menu of 6 days according to their metabolic requirements and a list of equivalent foods. A list of foods classified as having low index and glycemic load was used according to the mexican equivalent food system. The distribution of macronutrients will be: 45% carbohydrates, 30% lipids and 25% proteins. Milk and vitamin supplements will be eliminated from the diet.

Drug: Adapalene 0.1% Gel
Adapalene 0.1% gel daily at night for 12 weeks, applied on the face, chest and back.
Other Name: Adapalene

Drug: Doxycycline
Doxycycline 100 mg per day orally, before breakfast




Primary Outcome Measures :
  1. Count of inflammatory acne lesions [ Time Frame: 12 weeks ]
    Number of papules and pustules


Secondary Outcome Measures :
  1. Count of non-inflammatory acne lesions [ Time Frame: 12 weeks ]
    Number of comedones

  2. Changes in quality of life [ Time Frame: 12 weeks ]
    Score of the Dermatology Life Quality Index



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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Having moderate inflammatory acne
  • 18 to 25 years old
  • Male
  • 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
  • Severe acne that requires isotretinoin therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03585140


Sponsors and Collaborators
Centro Dermatológico Dr. Ladislao de la Pascua
Investigators
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Principal Investigator: Martha A Morales-Sánchez, MD Centro Dermatológico Dr. Ladislao de la Pascua

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Responsible Party: Dra. Martha Alejandra Morales Sánchez, MD, Centro Dermatológico Dr. Ladislao de la Pascua
ClinicalTrials.gov Identifier: NCT03585140     History of Changes
Other Study ID Numbers: 106/2016
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dra. Martha Alejandra Morales Sánchez, Centro Dermatológico Dr. Ladislao de la Pascua:
Acne Vulgaris
Low Glycemic Diet
Doxycycline
Adapalene
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Doxycycline
Adapalene
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
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