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CompletedNCT03585140Updated Jul 16, 2018

Low Glycemic Index and Load Diet for the Treatment of Acne

An interventional study of Normal diet and Low glycemic diet in Acne Vulgaris and Diet Modification, sponsored by Centro Dermatológico Dr. Ladislao de la Pascua. Completed. Open to male participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2018-07-16.

Sponsored by Centro Dermatológico Dr. Ladislao de la Pascua · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Jan 2016, registered Jun 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Acne Vulgaris
  • Diet Modification

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Keywords

  • Acne Vulgaris
  • Low Glycemic Diet
  • Doxycycline
  • Adapalene
03

In context

Acne Vulgaris

731 studies on the registry are indexed under Acne Vulgaris; 87 are open to participants now.

This study's enrollment of 52 is below the median of 69 across 629 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Centro Dermatológico Dr. Ladislao de la Pascua is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
52 participants (actual)

Study arms

  • Active comparator
    Normal Diet

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

    Other: Normal diet · Drug: Adapalene 0.1% Gel · Drug: Doxycycline

  • 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 · Drug: Adapalene 0.1% Gel · Drug: Doxycycline

Interventions

  • OtherNormal 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.

  • OtherLow 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.

  • DrugAdapalene 0.1% Gel

    Adapalene 0.1% gel daily at night for 12 weeks, applied on the face, chest and back.

    Also known as: Adapalene

  • DrugDoxycycline

    Doxycycline 100 mg per day orally, before breakfast

06

What researchers measure

Primary outcomes

  1. Count of inflammatory acne lesions

    Number of papules and pustules

    Time frame: 12 weeks

Secondary outcomes

  1. Count of non-inflammatory acne lesions

    Number of comedones

    Time frame: 12 weeks

  2. Changes in quality of life

    Score of the Dermatology Life Quality Index

    Time frame: 12 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03585140
Lead sponsor
Centro Dermatológico Dr. Ladislao de la Pascua
Responsible party
Dra. Martha Alejandra Morales Sánchez (MD, Centro Dermatológico Dr. Ladislao de la Pascua) — Principal investigator
First posted
Jul 12, 2018
Start date
Jan 1, 2016
Primary completion
May 1, 2016
Completion
Nov 30, 2016
Last update
Jul 16, 2018

Study contacts

Martha A Morales-Sánchez, MD
principal investigator · Centro Dermatológico Dr. Ladislao de la Pascua

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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