Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

Conditions

Acne Vulgaris

Brief summary

This is a multicenter, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of IDP-126 Gel in comparison IDP-126 Vehicle Gel at Weeks 2, 4, 8, and 12.

Leon H Kircik, Edward Lain, Hilary Baldwin, Linda Stein Gold, Joshua Zeichner et al. (10 authors)

SKIN The Journal of Cutaneous Medicine2026-05-11

10.25251/j35dfs02

Clindamycin Phosphate 1.2%/Adapalene 0.15%/ Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne: A Pooled Analysis by Age.

Kircik LH, Harper JC, Baldwin H, Eichenfield LF, Tanghetti EA, Graber E, Woolery-Lloyd HC, Guenin E, Draelos ZD.

2025-12-01

10.36849/jdd.9407

Efficacy and Safety of Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Asian Participants With Moderate to Severe Acne

George Han, Andrew Alexis, Neal Bhatia, Valerie Callender, Hilary Baldwin et al. (7 authors)

SKIN The Journal of Cutaneous Medicine2025-11-10

10.25251/0ezq2n61

Safety and Tolerability of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Truncal Acne.

Kircik LH, Harper JC, Gold M, Gold LS, Draelos ZD, Guenin E, Choi SY, Wroblewski K, Baldwin H, Callender VD, Hebert AA, Weiss JS.

2025-08-01

10.36849/jdd.9212

Safety and Tolerability of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Truncal Acne

Leon Kircik, Julie Harper, Michael A. Gold, Linda Stein Gold, Zoe Draelos et al. (12 authors)

SKIN The Journal of Cutaneous Medicine2025-07-23

10.25251/aws2gn51

Efficacy and Safety of Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Black Participants With Moderate to Severe Acne

Andrew Alexis, Valerie Callender, Neal Bhatia, Julie Harper, Eric Guenin et al. (6 authors)

SKIN The Journal of Cutaneous Medicine2025-07-23

10.25251/66kty944

Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel: Post Hoc Analysis by Baseline Disease Severity.

Gold M, Lain T, Harper JC, Baldwin H, Guenin E, Stein Gold L.

2025-05-16

10.1007/s13555-025-01440-z

Efficacy and Safety of Fixed-dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Black Participants with Moderate to Severe Acne.

Callender VD, Alexis AF, Bhatia N, Harper JC, Baldwin H, Guenin E, Kircik LH.

2025-04-01

10.1016/j.jaad.2024.07.772

Efficacy and safety of fixed-dose clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% gel in Hispanic participants with moderate-to-severe acne: a pooled analysis.

Callender VD, Baldwin H, Gold LS, Cook-Bolden FE, Guenin E, Alexis AF.

2025-03-23

10.1080/09546634.2025.2480232

Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne in Children and Adolescents.

Eichenfield LF, Hebert AA, Harper JC, Baldwin H, Bhatia N, Gold LS, Kircik LH, Graber E, Tanghetti EA, Alexis AF, Del Rosso JQ.

2024-12-01

10.36849/jdd.8643

Efficacy and Safety of Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Participants with Moderate-to-Severe Acne: The Patient Journey

Hilary Baldwin, Julie Harper, Joshua Zeichner, Zoe Draelos, Lawrence F. Eichenfield et al. (9 authors)

SKIN The Journal of Cutaneous Medicine2024-11-18

10.25251/skin.8.supp.494

Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel: Post Hoc Analysis by Baseline Disease Severity

Michael A. Gold, Edward Lain, Julie Harper, Hilary Baldwin, Linda Stein Gold et al. (6 authors)

SKIN The Journal of Cutaneous Medicine2024-11-18

10.25251/skin.8.supp.497

Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Participants With Moderate-to-Severe Acne: The Patient Journey.

Baldwin H, Harper JC, Zeichner JA, Draelos ZD, Eichenfield LF, Gold M, Gold LS, Kircik LH.

2024-11-01

10.36849/jdd.8639

Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Male and Female Acne: Phase 3 Analysis.

Lain ET, Bhatia N, Kircik L, Gold LS, Harper JC, Bunick CG, Guenin E, Baldwin H, Feldman SR, Rosso JQD.

2024-10-01

10.36849/jdd.2024.8484

Impact of Age on Efficacy and Safety of Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Participants with Moderate-to-Severe Acne

Leon Kircik, Julie Harper, Hilary Baldwin, Lawrence F. Eichenfield, Emil Tanghetti et al. (8 authors)

SKIN The Journal of Cutaneous Medicine2024-07-23

10.25251/skin.8.supp.415

Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne: Comparison of 4 Clinical Trials

Leon Kircik, Zoé Kececioglu Draelos, M. Gold, Neil S. Sadick, Neal Bhatia

SKIN The Journal of Cutaneous Medicine2024-07-23

10.25251/skin.8.supp.416

Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Acne in Adult and Pediatric Participants.

Baldwin H, Gold LS, Harper JC, Alexis AF, Callender VD, Kircik L, Guenin E, Eichenfield LF.

2024-06-01

10.36849/jdd.8357

Triple Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Acne: Efficacy and Safety from a Pooled Phase 3 Analysis

Leon Kircik, Linda Stein Gold, M. Gold, Jonathan S. Weiss, Julie Harper et al. (19 authors)

Dermatology and Therapy2024-05-016 citations

10.1007/s13555-024-01155-7

Efficacy and Safety of Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Females with Moderate to Severe Acne: Post Hoc Analysis by Age

Julie Harper, Linda Stein Gold, Hilary Baldwin, Valerie Callender, M. Gold et al. (7 authors)

SKIN The Journal of Cutaneous Medicine2024-03-18

10.25251/skin.8.supp.392

Early Acne Improvements With Fixed-Dose Clindamycin Phosphate 1.2%/ Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel: What to Expect in the First 4 Weeks of Treatment

Julie Harper, Leon Kircik, Michael A. Gold, Adelaide A. Hebert, Jeremy Sugarman et al. (10 authors)

SKIN The Journal of Cutaneous Medicine2024-03-18

10.25251/skin.8.supp.393

Efficacy and Safety of Fixed-Dose Triple-Combination Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel for Moderate-to-Severe Acne Vulgaris in Children and Adolescents

Lawrence F. Eichenfield, Adelaide A. Hebert, Julie Harper, Hilary Baldwin, Neal Bhatia et al. (11 authors)

SKIN The Journal of Cutaneous Medicine2024-03-18

10.25251/skin.8.supp.390

Early and Sustained Acne Lesion Reductions With Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel.

Harper JC, Kircik LH, Gold M, Hebert AA, Sugarman JL, Green L, Gold LS, Baldwin H, Guenin E, DelRosso JQ.

2024-03-011 citations

10.36849/jdd.7907

Safety and Tolerability of Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% Gel in Black Participants With Acne

Valerie Callender, Fran Cook-Bolden, Leon Kircik, Jonathan M. Weiss, Andrew Alexis et al. (10 authors)

SKIN The Journal of Cutaneous Medicine2024-01-161 citations

10.25251/skin.8.supp.340

Triple-Combination Fixed-Dose Clindamycin Phosphate 1.2%/Adapalene 0.15%/Benzoyl Peroxide 3.1% for Moderate-to-Severe Acne: Efficacy and Safety Results From a Pooled Phase 3 Analysis

Linda Stein Gold, Michael H. Gold, Leon Kircik, Julie Harper, J.Q. Del Rosso et al. (11 authors)

SKIN The Journal of Cutaneous Medicine2024-01-16

10.25251/skin.8.supp.339

Impact of Age or Sex on Efficacy and Safety of a Fixed-Dose Clindamycin Phosphate 1.2%/Benzoyl Peroxide 3.1%/Adapalene 0.15% Gel in Participants with Moderate-to-Severe Acne

Linda Stein Gold, Leon Kircik, William Philip Werschler, Hilary Baldwin, Valerie Callender et al. (11 authors)

SKIN The Journal of Cutaneous Medicine2023-07-17

10.25251/skin.7.supp.222

Interventions

DRUGIDP-126 Gel

IDP-126 Gel applied topically to the face once daily for 12 weeks.

DRUGIDP-126 Vehicle Gel

IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

9 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Male or female at least 9 years of age and older. * Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit). * Subject must have an Evaluator's Global Severity Score (EGSS) of 3 (moderate) or 4 (severe) at the baseline visit. * Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 30, but no more than 100. * Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count no less than 35, but no more than 150. * Subjects with 2 or fewer facial nodules.

Exclusion criteria

* Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram negative folliculitis, dermatitis, eczema. * Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive. * Subjects with more than 2 facial nodules. * Female subjects who are pregnant, nursing mothers, planning a pregnancy during the course of the study, or become pregnant during the study. * Use of estrogens (eg, Depogen, Depo-Testadiol, Gynogen, Valergen, etc) for less than 12 weeks immediately preceding study entry; subjects treated with estrogens 12 or more consecutive weeks immediately prior to study entry need not be excluded unless the subject expects to change dose, drug or discontinue estrogen use during the study. * Treatment of any type of cancer within the last 6 months, with the exception of complete surgical excision of skin cancer outside the treatment area. * Subjects who have not undergone specified washout period(s) for topical preparations/physical treatments used on the face or subjects who require the concurrent use in the treatment area. * Subjects who have not undergone specified washout period(s) for systemic medications or subjects who require the concurrent use of systemic medications. * Subjects with any underlying disease that the investigator deems uncontrolled, and poses a concern for the subject's safety while participating in the study.

Design outcomes

Primary

Measure	Time frame	Description
Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts	12 weeks	—
Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts	12 weeks	—
Percentage of Participants With Success on the Evaluator's Global Severity Score	12 weeks	Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.

Secondary

Measure	Time frame	Description
Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12	Baseline to Week 4, 8, 12	—
Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12	Baseline to Week 4, 8, 12	—
Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score at Week 12	12 weeks	The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.

Countries

Canada, United States

Participant flow

Participants by arm

Arm	Count
IDP-126 Gel IDP-126 Gel: IDP-126 Gel applied topically to the face once daily for 12 weeks.	120
IDP-126 Vehicle Gel IDP-126 Vehicle Gel: IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.	60
Total	180

Baseline characteristics

Characteristic	IDP-126 Vehicle Gel	Total	IDP-126 Gel
Age, Continuous	19.5 years	18.0 years	17.0 years
Baseline Evaluator's Global Severity Score Moderate	57 Participants	166 Participants	109 Participants
Baseline Evaluator's Global Severity Score Severe	3 Participants	14 Participants	11 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	9 Participants	8 Participants
Race (NIH/OMB) Black or African American	5 Participants	17 Participants	12 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	7 Participants	6 Participants
Race (NIH/OMB) White	53 Participants	147 Participants	94 Participants
Sex: Female, Male Female	37 Participants	106 Participants	69 Participants
Sex: Female, Male Male	23 Participants	74 Participants	51 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 120	0 / 60
other Total, other adverse events	18 / 120	1 / 60
serious Total, serious adverse events	0 / 120	0 / 60

Outcome results

Primary

Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts

Time frame: 12 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
IDP-126 Gel	Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts	-30.1 lesion counts	Standard Deviation 9.64
IDP-126 Vehicle Gel	Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts	-20.8 lesion counts	Standard Deviation 9.9

Primary

Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts

Time frame: 12 weeks

Arm	Measure	Value (LEAST_SQUARES_MEAN)	Dispersion
IDP-126 Gel	Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts	-35.2 lesion counts	Standard Deviation 14.48
IDP-126 Vehicle Gel	Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts	-22.0 lesion counts	Standard Deviation 14.27

Primary

Percentage of Participants With Success on the Evaluator's Global Severity Score

Success was defined as at least a two grade reduction and clear or almost clear at Week 12. The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.

Time frame: 12 weeks

Arm	Measure	Value (NUMBER)
IDP-126 Gel	Percentage of Participants With Success on the Evaluator's Global Severity Score	50.5 percentage of participants
IDP-126 Vehicle Gel	Percentage of Participants With Success on the Evaluator's Global Severity Score	20.5 percentage of participants

Secondary

Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12

Time frame: Baseline to Week 4, 8, 12

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
IDP-126 Gel	Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12	Week 12	-80.13 percentage change	Standard Deviation 25.274
IDP-126 Gel	Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12	Week 4	-57.40 percentage change	Standard Deviation 29.412
IDP-126 Gel	Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12	Week 8	-70.38 percentage change	Standard Deviation 27.018
IDP-126 Vehicle Gel	Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12	Week 8	-47.62 percentage change	Standard Deviation 26.343
IDP-126 Vehicle Gel	Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12	Week 12	-56.18 percentage change	Standard Deviation 25.149
IDP-126 Vehicle Gel	Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12	Week 4	-41.62 percentage change	Standard Deviation 26.854

Secondary

Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12

Time frame: Baseline to Week 4, 8, 12

Arm	Measure	Group	Value (LEAST_SQUARES_MEAN)	Dispersion
IDP-126 Gel	Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12	Week 4	-45.07 percentage change	Standard Deviation 32.748
IDP-126 Gel	Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12	Week 8	-60.62 percentage change	Standard Deviation 28.041
IDP-126 Gel	Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12	Week 12	-73.26 percentage change	Standard Deviation 27.64
IDP-126 Vehicle Gel	Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12	Week 4	-33.05 percentage change	Standard Deviation 29.29
IDP-126 Vehicle Gel	Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12	Week 8	-45.54 percentage change	Standard Deviation 26.604
IDP-126 Vehicle Gel	Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12	Week 12	-48.99 percentage change	Standard Deviation 27.345

Secondary

Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score at Week 12

The Evaluator's Global Severity Score has grades for acne severity of 0 (Clear), 1 (Almost Clear), 2 (Mild), 3 (Moderate), and 4 (Severe), with higher scores indicating worse severity.

Time frame: 12 weeks

Arm	Measure	Value (NUMBER)
IDP-126 Gel	Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score at Week 12	55.2 percentage of participants
IDP-126 Vehicle Gel	Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score at Week 12	23.1 percentage of participants

Clinical Study Comparing the Efficacy and Safety of IDP-126 Gel in the Treatment of Acne Vulgaris

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Participants by arm

Baseline characteristics

Adverse events

Outcome results

Absolute Change From Baseline to Week 12 in Inflammatory Lesion Counts

Absolute Change From Baseline to Week 12 in Non-inflammatory Lesion Counts

Percentage of Participants With Success on the Evaluator's Global Severity Score

Inflammatory Lesion Count Percentage Changes at Week 4, 8, and 12

Noninflammatory Lesion Count Percentage Changes at Week 4, 8, and 12

Percentage of Participants With at Least a Two Grade Reduction on the Evaluator's Global Severity Score at Week 12