NCT03585140

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
Last Updated

July 16, 2018

Status Verified

July 1, 2018

Enrollment Period

4 months

First QC Date

June 29, 2018

Last Update Submit

July 12, 2018

Conditions

Acne VulgarisDiet Modification

Keywords

Acne VulgarisLow Glycemic DietDoxycyclineAdapalene

Outcome Measures

Primary Outcomes (1)

  • Count of inflammatory acne lesions

    Number of papules and pustules

    12 weeks

Secondary Outcomes (2)

  • Count of non-inflammatory acne lesions

    12 weeks

  • Changes in quality of life

    12 weeks

Study Arms (2)

Normal Diet

ACTIVE COMPARATOR

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

Other: Normal dietDrug: Adapalene 0.1% GelDrug: Doxycycline

Low glycemic diet

EXPERIMENTAL

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 dietDrug: Adapalene 0.1% GelDrug: Doxycycline

Interventions

Normal dietOTHER

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.

Normal Diet
Low glycemic dietOTHER

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.

Low glycemic diet
Adapalene 0.1% GelDRUG

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

Also known as: Adapalene
Low glycemic dietNormal Diet
DoxycyclineDRUG

Doxycycline 100 mg per day orally, before breakfast

Low glycemic dietNormal Diet

Eligibility Criteria

Age18 Years - 25 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acne Vulgaris

Interventions

AdapaleneGelsDoxycycline

Condition Hierarchy (Ancestors)

Acneiform EruptionsSkin DiseasesSkin and Connective Tissue DiseasesSebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsColloidsComplex MixturesDosage FormsPharmaceutical PreparationsTetracyclinesNaphthacenes

Study Officials

  • Martha A Morales-Sánchez, MD

    Centro Dermatológico Dr. Ladislao de la Pascua

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Diet intervention was made by the nutrition specialist. Neither the principal investigator nor the outcome assessor were aware about the group of diet intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized clinical trial, two-arm
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 29, 2018

First Posted

July 12, 2018

Study Start

January 1, 2016

Primary Completion

May 1, 2016

Study Completion

November 30, 2016

Last Updated

July 16, 2018

Record last verified: 2018-07