Trial Outcomes & Findings for Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide (BPO) 2.5% in Dark Skin Acne (NCT NCT02932267)

Last Updated: 2021-02-18

Results Overview

% of subjects satisfied to very satisfied with study treatment at week 12

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

50 participants

Primary outcome timeframe

At week 12

Results posted on

2021-02-18

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

Participant milestones
Measure	Adapalene / BPO Gel 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 Study STARTED	50
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	8

Reasons for withdrawal
Measure	Adapalene / BPO Gel 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 Study Withdrawal by Subject	3
Overall Study Lost to Follow-up	4
Overall Study Pregnancy	1

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

Baseline characteristics by cohort
Measure	Adapalene / BPO Gel n=50 Participants 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
Age, Categorical <=18 years	21 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	20.9 years STANDARD_DEVIATION 6.4 • n=99 Participants
Sex: Female, Male Female	24 Participants n=99 Participants
Sex: Female, Male Male	26 Participants n=99 Participants
Race/Ethnicity, Customized Asian	20 Participants n=99 Participants
Race/Ethnicity, Customized Latin American	13 Participants n=99 Participants
Race/Ethnicity, Customized Black/African-American	17 Participants n=99 Participants
Region of Enrollment Singapore	16 participants n=99 Participants
Region of Enrollment United States	18 participants n=99 Participants
Region of Enrollment Mauritius	16 participants n=99 Participants
Skin phototype Phototype IV	37 Participants n=99 Participants
Skin phototype Phototype V	11 Participants n=99 Participants
Skin phototype Phototype VI	2 Participants n=99 Participants

Timeframe: At week 12

Population: Intent-to-treat (ITT) population. Here 'N' (number analyzed) signifies number of participants evaluable for this outcome measure.

% of subjects satisfied to very satisfied with study treatment at week 12

Outcome measures
Measure	Adapalene / BPO Gel n=47 Participants 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
Subject 's Overall Satisfaction With Study Treatment Via a Satisfaction Questionnaire	36 Participants

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Adapalene / BPO Gel n=50 participants at risk 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
General disorders Pyrexia	4.0% 2/50 • Number of events 2 • Up to 16 Weeks
Nervous system disorders Headache	6.0% 3/50 • Number of events 4 • Up to 16 Weeks
Skin and subcutaneous tissue disorders Post inflammatory pigmentation change	4.0% 2/50 • Number of events 2 • Up to 16 Weeks
Skin and subcutaneous tissue disorders Pruritus	4.0% 2/50 • Number of events 3 • Up to 16 Weeks

Galderma

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