POWER: Efficacy & Safety Comparison of Epiduo With Doxycycline Versus Vehicle With Isotretinoin in the Treatment of Severe Acne

• Sponsor: Galderma R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01474590
• Collaborator: (none)
• Enrollment: 266
• Locations: 26
• Arms: 2
• Duration (Months): 21
• Patients Per Site: 10.2
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Non-inferiority, randomized, controlled, multi-center, investigator-blind, parallel-group comparison study in subjects with severe acne vulgaris on the face.

Condition or Disease	Intervention/Treatment	Phase
Acne	Drug: Epiduo/Tactuo; Other: vehicle gel; Drug: doxycycline 200mg; Drug: Isotretinoin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 266 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With 200 mg Doxycycline Capsules Versus Vehicle Gel Associated With Isotretinoin Capsules in the Treatment of Severe Acne
• Study Start Date: Nov 1, 2011
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Epiduo/Tactuo + doxycycline 200mg	Drug: Epiduo/Tactuo; topical to the face, once daily in the evening; Drug: doxycycline 200mg; oral, 2 capsules once daily in the morning with aglass of water and with food
Active Comparator: Isotretinoin + vehicle gel	Other: vehicle gel; topical to the face, once daily in the evening; Drug: Isotretinoin; oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.

Outcome Measures

Primary Outcome Measures

1. The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements [20 weeks]

   Overall success is reached when the 2 following criteria are fulfilled : Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment Safe treatment: Absence of any listed safety issues

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Male or female subject of any race, aged 12 to 35 years inclusive

2. Subject weighing between 50 and 110 kg

3. Subject with severe acne (IGA at least 4), which in the opinion of the investigator is appropriate for treatment with oral isotretinoin (severe nodular acne, severe inflammatory acne, recalcitrant acne; all unresponsive to conventional first line therapies)

4. Subject with at least 5 nodules on the face

Exclusion Criteria:

1. Subject with clinically abnormal results to blood testings performed at screening

2. Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), pyoderma faciale, sinus tracks

3. Female subject who is pregnant, nursing or planning a pregnancy during the study

4. Subject with known history of hepatic and/or renal insufficiency, to be confirmed by blood testings

5. Subject with known metabolic or structural bone disease (for 12-17 years old population)

6. Subject with bowel disease and/or with hypervitaminosis A

7. Subject who presents with treated or untreated depression or has a history of depression including a family history of major depression

8. Subject with a wash-out period from baseline for topical treatment on the face less than : Corticosteroids, antibiotics, antibacterials, antiseptics, retinoids, other anti-inflammatory drugs or other acne treatments (2 weeks); Cosmetic procedures (1 week); Photodynamic therapy and laser therapy for acne (3 months)

9. Subject with a wash-out period from baseline for systemic treatment less than: Corticosteroids, antibiotics (4 weeks),Progesterone for contraception (3 months); Spironolactone(3 months); Other acne treatments (6 months);Cyproterone acetate(6 months)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Galderma investigational site	Ajax		Canada
2	Galderma investigational site	Barrie		Canada
3	Galderma investigational site	Calgary		Canada
4	Galderma investigational site	Edmonton		Canada
5	Galderma investigational site	Halifax		Canada
6	Galderma investigational site	Hamilton		Canada
7	Galderma investigational site	Markham		Canada
8	Galderma investigational site	Montreal		Canada
9	Galderma investigational site	Newmarket		Canada
10	Galderma investigational site	Oakville		Canada
11	Galderma investigational site	Oshawa		Canada
12	Galderma investigational site	Peterborough		Canada
13	Galderma investigational site	Quebec city		Canada
14	Galderma investigational site	Richmond Hill		Canada
15	Galderma investigational site	Saint-Hyacinthe		Canada
16	Galderma investigational site	Saint-John's		Canada
17	Galderma investigational site	Saskatoon		Canada
18	Galderma investigational site	St John's		Canada
19	Galderma investigational site	Sudbury		Canada
20	Galderma investigational site	Surrey		Canada
21	Galderma investigational site	Toronto		Canada
22	Galderma investigational site	Vancouver		Canada
23	Galderma investigational site	Waterloo		Canada
24	Galderma investigational site	Windsor		Canada
25	Galderma investigational site	Winnipeg		Canada
26	Galderma investigational site	Woodbridge		Canada

Sponsors and Collaborators

• Galderma R&D

Investigators

• Principal Investigator: Jerry Tan, Windsor Clinical Research Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Galderma R&D
• ClinicalTrials.gov Identifier: NCT01474590
• Other Study ID Numbers: RD.03.SPR.29099
• First Posted: Nov 18, 2011
• Last Update Posted: Feb 18, 2021
• Last Verified: Aug 1, 2017

• Additional relevant MeSH terms: Acne Vulgaris; Doxycycline; Isotretinoin

Study Results

Participant Flow

Arm/Group Title	Epiduo/Tactuo + Doxycycline 200mg	Isotretinoin + Vehicle Gel
Arm/Group Description	Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.	Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
Period Title: Overall Study
STARTED	133	133
COMPLETED	105	116
NOT COMPLETED	28	17

Baseline Characteristics

Arm/Group Title	Epiduo/Tactuo + Doxycycline 200mg	Isotretinoin + Vehicle Gel	Total
Arm/Group Description	Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.	Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.	Total of all reporting groups
Overall Participants	133	133	266
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	19.5 (5.0)	19.3 (4.5)	19.4 (4.8)
Sex: Female, Male (Count of Participants)
Female	18 13.5%	21 15.8%	39 14.7%
Male	115 86.5%	112 84.2%	227 85.3%
Region of Enrollment (count of participants) [Number]
Canada	133 100%	133 100%	266 100%
IGA (count of participants) [Number]
4	118 88.7%	115 86.5%	233 87.6%
5	15 11.3%	18 13.5%	33 12.4%
nodule counts (nodules) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [nodules]	8.0 (3.6)	7.6 (2.5)	7.8 (3.1)

Outcome Measures

1. Primary Outcome

Title	The Primary Outcome is Overall Success, a Composite Endpoint Including Efficacy and Safety Measurements
Description	Overall success is reached when the 2 following criteria are fulfilled : Overall efficacy: reduction of at least 75% of number of nodules at the end of treatment Safe treatment: Absence of any listed safety issues
Time Frame	20 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Epiduo/Tactuo + Doxycycline 200mg	Isotretinoin + Vehicle Gel
Arm/Group Description	Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.	Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
Measure Participants	133	133
Number [count of participants]	85 63.9%	73 54.9%

Adverse Events

Time Frame	20 weeks
Arm/Group Title	Epiduo/Tactuo + Doxycycline 200mg		Isotretinoin + Vehicle Gel
Arm/Group Description	Epiduo/Tactuo + doxycycline 200mg: Epiduo gel: topical to the face, once daily in the evening Doxycycline: oral, 2 capsules a day. The capsules should be taken with a glass of water and with food either as a single dose or in two divided doses during the day.		Isotretinoin + vehicle gel: Vehicle gel: topical to the face, once daily in the evening Isotretinoin: oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
All Cause Mortality
	Epiduo/Tactuo + Doxycycline 200mg		Isotretinoin + Vehicle Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Epiduo/Tactuo + Doxycycline 200mg		Isotretinoin + Vehicle Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/133 (0%)		1/133 (0.8%)
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome	0/133 (0%)	0	1/133 (0.8%)	1
Other (Not Including Serious) Adverse Events
	Epiduo/Tactuo + Doxycycline 200mg		Isotretinoin + Vehicle Gel
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/133 (18.8%)		66/133 (49.6%)
Gastrointestinal disorders
lip dry	9/133 (6.8%)	9	66/133 (49.6%)	72
nausea	14/133 (10.5%)	14	5/133 (3.8%)	5
vomiting	12/133 (9%)	14	2/133 (1.5%)	2
cheilitis	2/133 (1.5%)	2	32/133 (24.1%)	33
Infections and infestations
naospharyngitis	15/133 (11.3%)	17	14/133 (10.5%)	17
UPTRI (Upper Tract Respiratory Infection)	9/133 (6.8%)	10	13/133 (9.8%)	16
Nervous system disorders
headache	12/133 (9%)	14	11/133 (8.3%)	12
Skin and subcutaneous tissue disorders
dry skin	25/133 (18.8%)	31	43/133 (32.3%)	56
skin irritation	14/133 (10.5%)	17	7/133 (5.3%)	8

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.