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Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide (BPO) 2.5% in Dark Skin Acne (EDeN)

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ClinicalTrials.gov Identifier: NCT02932267
Recruitment Status : Completed
First Posted : October 13, 2016
Results First Posted : November 15, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Galderma

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Acne Vulgaris
Intervention Drug: Adapalene 0.3% / BPO 2.5% gel
Enrollment 50
Recruitment Details  
Pre-assignment Details Wash-out period for topical treatment or procedures of 1 week to 3 months and for systemic treatment for 1 month to 3 months, depending on treatment
Arm/Group Title Adapalene / BPO Gel
Hide Arm/Group Description

Adapalene 0.3% / BPO 2.5% gel, once daily in the evening

Adapalene 0.3% / BPO 2.5% gel: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks

Period Title: Overall Study
Started 50
Completed 42
Not Completed 8
Reason Not Completed
Withdrawal by Subject             3
Lost to Follow-up             4
Pregnancy             1
Arm/Group Title Adapalene / BPO Gel
Hide Arm/Group Description

Adapalene 0.3% / BPO 2.5% gel, once daily in the evening

Adapalene 0.3% / BPO 2.5% gel: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks

Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
ITT population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
<=18 years
21
  42.0%
Between 18 and 65 years
29
  58.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
20.9  (6.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
24
  48.0%
Male
26
  52.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Asian
20
  40.0%
Latin American
13
  26.0%
Black/African-American
17
  34.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 50 participants
Singapore 16
United States 18
Mauritius 16
Skin phototype   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Phototype IV
37
  74.0%
Phototype V
11
  22.0%
Phototype VI
2
   4.0%
[1]
Measure Description: Fitzpatrick skin phototype is a system used to describe a person's skin type. It ranges from skin phototype I to VI. Where, skin phototype I = pale white skin, always burns easily, never tans; skin phototype II = fair skin, always burns easily, tans minimally and with difficulty; skin phototype III = darker white skin, burns minimally, tans gradually and uniformly; skin phototype IV = light brown skin, burns minimally, always tans well; skin phototype V = brown skin, rarely burns, tans profusely; skin phototype VI = dark brown or black skin, never burns, tans profusely.
1.Primary Outcome
Title Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire
Hide Description % of subjects satisfied to very satisfied with study treatment at week 12
Time Frame At week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population
Arm/Group Title Adapalene / BPO Gel
Hide Arm/Group Description:

Adapalene 0.3% / BPO 2.5% gel, once daily in the evening

Adapalene 0.3% / BPO 2.5% gel: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks

Overall Number of Participants Analyzed 47
Measure Type: Count of Participants
Unit of Measure: Participants
36
  76.6%
Time Frame Up to 16 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adapalene / BPO Gel
Hide Arm/Group Description

Adapalene 0.3% / BPO 2.5% gel, once daily in the evening

Adapalene 0.3% / BPO 2.5% gel: Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks

All-Cause Mortality
Adapalene / BPO Gel
Affected / at Risk (%)
Total   0/50 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Adapalene / BPO Gel
Affected / at Risk (%) # Events
Total   0/50 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Adapalene / BPO Gel
Affected / at Risk (%) # Events
Total   9/50 (18.00%)    
General disorders   
Pyrexia  1  2/50 (4.00%)  2
Nervous system disorders   
Headache  1  3/50 (6.00%)  4
Skin and subcutaneous tissue disorders   
Post inflammatory pigmentation change  1  2/50 (4.00%)  2
Pruritus  1  2/50 (4.00%)  3
1
Term from vocabulary, MedDRA (19.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Rajeev Chavda
Organization: Galderma
Phone: 0033 ext 492382928
EMail: rajeev.chavda@galderma.com
Layout table for additonal information
Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT02932267     History of Changes
Other Study ID Numbers: RD.03.SPR.110232
First Submitted: October 11, 2016
First Posted: October 13, 2016
Results First Submitted: September 26, 2018
Results First Posted: November 15, 2019
Last Update Posted: November 15, 2019