Clinical trial NCT06336603: A Study Assessing the Efficacy of Combined Use of Clascoterone 1% Cream and Adapalene 0.3% for the Treatment of Acne
Official title: The Combination Use of Winlevi and Adapalene 0.3% Gel in Real Life Acne Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acne Vulgaris
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2024-03-29
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Winlevi is the first topical anti androgen and sebum inhibitor approved for acne vulgaris. There is no study assessing Winlevi in combination treatment for acne .Therefore this study assesses Winlevi with Adapalene 0.3% gel in combination to emulate real life practice.


Eligibility criteria: Inclusion Criteria:

i. Outpatient, male or female subjects of any race, and at least 12 years of age or older.

* Female subjects of childbearing potential must have a negative urine pregnancy test result at Baseline (test must have a sensitivity of at least 25mIU/ml for human chorionic gonadotropin) and practice a reliable method of contraception throughout the study:
* A female is considered of childbearing potential unless she is:

  1. postmenopausal for at least 12 months prior to study drug administration;
  2. without a uterus and/or both ovaries; or
  3. Has been surgically sterile for at least 6 months prior to study drug administration.
* Reliable methods of contraception are:

  1. Hormonal methods or intrauterine device in use \> 90 days prior to study drug administration;
  2. Barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
  3. Vasectomized partner (vasectomy must be performed 3 months prior to first study drug administration or in the alternative a zero sperm count will suffice).
* Exception: Female subjects of childbearing potential who are not sexually active will not be required to practice a reliable method of contraception. These subjects may be enrolled at the Investigator's discretion if they are counseled to remain sexually inactive during the study and understand the possible risks in getting pregnant during the study.

ii. Facial acne IGA score of 3 or 4.

iii. Able to understand the requirements of the study and sign Informed Consent/HIPAA Authorization forms. Subjects under the legal age of consent in the state where the study is conducted must also have the written, informed consent of a parent or legal guardian.

Exclusion Criteria:

i. Female subjects who are pregnant (positive urine pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control.

ii. Allergy or sensitivity to any component of the test medications (Section 5.2).

iii. Subjects who have not complied with the proper wash-out periods for prohibited medications (Supplement I).

iv. Medical condition that, in the opinion of the Investigator, contraindicates the subject's participation in the clinical study.

v. Skin disease/disorder that might interfere with the diagnosis or evaluation of acne vulgaris vi. Evidence of recent alcohol or drug abuse. vii. History of poor cooperation, non-compliance with medical treatment, or unreliability.

viii. Exposure to an investigational drug study within 30 days of the Baseline Visit.

Primary outcomes:
measure: The primary endpoint of this study is the percent of patients who achieve clear or almost clear on IGA at week 16.
timeFrame: Week 16
Secondary outcomes:
measure: Percent of total lesion reduction at week 16 compared to baseline
timeFrame: Week 16
measure: Percent of inflammatory lesion reduction at week 16 compared to baseline
timeFrame: Week 16
measure: Percent of non-inflammatory lesion reduction at week 16 compared to baseline
timeFrame: Week 16
measure: Tolerability measures of erythema based on 5-point severity scale
timeFrame: Week 4,8,12,16, 20
measure: Tolerability measures of dryness based on 5-point severity scale
timeFrame: Week 4,8,12,16, 20
measure: Tolerability measures of peeling based on 5-point severity scale
timeFrame: Week 4,8,12,16, 20
measure: Assessment of skin oiliness based on 5-point severity scale
timeFrame: Week 4,8,12,16, 20
measure: Tolerability measures of burning/stinging based on 6-point severity scale
timeFrame: Week 4,8,12,16, 20
measure: Tolerability measures of pruritus based on 6-point severity scale
timeFrame: Week 4,8,12,16, 20
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Skin Sciences, PLLC
state: Kentucky
Study officials:
References: