Low Glycemic Index and Load Diet for the Treatment of Acne

Not Applicable

Completed

• Conditions: Acne Vulgaris; Diet Modification
• Interventions: Other: Normal diet; Other: Low glycemic diet; Drug: Adapalene 0.1% Gel; Drug: Doxycycline

• Registration Number: NCT03585140
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2016-01-01
• Primary Completion: 2016-05-01
• Study Completion: 2016-11-30
• Study First Submitted: 2018-06-29
• Status Verified: 2018-07
• Study First Submitted QC: 2018-07-11
• Study First Posted: 2018-07-12
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low glycemic diet	Adapalene 0.1% Gel	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.
Normal Diet	Normal diet	Participants will receive a normal diet according to their metabolic status.
Normal Diet	Adapalene 0.1% Gel	Participants will receive a normal diet according to their metabolic status.
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.
Normal Diet	Doxycycline	Participants will receive a normal diet according to their metabolic status.
Low glycemic diet	Doxycycline	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.

Primary Outcome Measures

Name	Time	Method
Count of inflammatory acne lesions	12 weeks	Number of papules and pustules

Secondary Outcome Measures

Name	Time	Method
Count of non-inflammatory acne lesions	12 weeks	Number of comedones
Changes in quality of life	12 weeks	Score of the Dermatology Life Quality Index