Safety and efficacy comparison of gel and emulgel formulations of tretinoin 0.025% and clindamaycin 1.2% for treatment of mild to moderate acne vulgaris
Safety and efficacy comparison of gel and emulgel formulations of tretinoin 0.025% and clindamaycin 1.2% for treatment of mild to moderate acne vulgaris
Design
The study is a phase 2, parallel treatment-control clinical trial. Sample size is 20. The study is randomized and double blinded. Randomization is done simply using a blind card, so names of the formulations are written on the same cards then each card is randomly selected for any side of the face.
Settings and conduct
The study will be performed in Center for the Study and Research of Diseases of the Skin and Leprosy, 20 volunteers with acne vulgaris will be selected and enrolled in the study after signing consent form. Volunteers will be taught to use “ of Tretinoin 0.025% and Clindamaycin 1.2% for 8 weeks once in a day. Before intervention and at the end of 4 and 8 weeks later changing in skin will be measured. This study is double blinded. The clinicians who performed the clinical assessments and objective device analysis are completely blinded to the treatment type. Participants will receive the treatment according to the randomization list by an independent assistant.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Male or female aged 16-40 years, Mild to moderate inflammatory or non-inflammatory acne lesions (grade 1 to 3 according to the table) on face
Exclusion criteria:
People with allergies to formulation ingredients, Nodular or cystic lesions that represent a severe type of acne vulgaris
Intervention groups
Intervention group: Topical use of emulgel formulations of tretinoin 0.025% and clindamaycin 1.2% for 8 weeks once in a day
Control group: Topical use of gel formulations of tretinoin 0.025% and clindamaycin 1.2% for 8 weeks once in a day
Main outcome variables
Evaluate of acne severity index by a physician
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150101020514N13
Registration date:2021-12-13, 1400/09/22
Registration timing:prospective
Last update:2021-12-13, 1400/09/22
Update count:0
Registration date
2021-12-13, 1400/09/22
Registrant information
Name
Alireza Firooz
Name of organization / entity
Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 8897 8190
Email address
firozali@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy comparison of gel and emulgel formulations of tretinoin 0.025% and clindamaycin 1.2% for treatment of mild to moderate acne vulgaris
Public title
Safety and efficacy comparison of gel and emulgel formulations of Tertinoin and Clindamaycin for treatment of mild to moderate acne vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Male or female aged 16-40 years
Mild to moderate inflammatory or non-inflammatory acne lesions (grade 1 to 3 according to the table) on face
Exclusion criteria:
People with allergies to formulation ingredients
Nodular or cystic lesions that represent a severe type of acne vulgaris
Age
From 16 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done simply using a blind card, so names of the formulations are written on the same cards then each card is randomly selected for any side of the face
Blinding (investigator's opinion)
Double blinded
Blinding description
Products of both groups are packed in similar boxes with different numeric code. In case of assessor blinding, the randomization list is given to a third person. The clinicians who performed the clinical assessments and objective device analysis are completely blinded to the treatment type. participants will receive the treatment according to the randomization list by an independent assistant.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Room 105 , 5th floor, Central construction of Tehran University of Medical Sciences, Ghods intersection, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2021-05-31, 1400/03/10
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.199
Health conditions studied
1
Description of health condition studied
Acne vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
Evaluate the improvement of acne severity index by a physician
Timepoint
Before intervention, 4 and 8 weeks after the start of use
Method of measurement
An independent dermatologists perform evaluation and scoring with the help of photos based on the percentage of improvement in acne using:(0=normal skin, 2=skin is almost clear, 3=some non-inflammatory lesions are present, 4=non-inflammatory lesions are predominant, with multiple inflammatory lesions. 5=highly inflammatory lesions predominate)
Secondary outcomes
1
Description
Trans Epidermal Water Loss
Timepoint
Before intervention, 4 and 8 weeks after the start of use
Method of measurement
Tewameter
2
Description
Skin sebum
Timepoint
Before intervention, 4 and 8 weeks after the start of use
Method of measurement
Sebumeter
Intervention groups
1
Description
Intervention group: Topical application of compounding emulgel (not industrial) containing tretinoin 0.025% and clindamaycin 1.2% on acne lesions of one side of the face (randomly) once a day (before sleeping), for 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Topical application of compounding gel (not industrial) containing tretinoin 0.025% and clindamaycin 1.2% on acne lesions of one side of the face (randomly) once a day (before sleeping), for 8 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Center for research and training in skin diseases and leprosy