Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04466527
Other study ID # 2020P000838
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 20, 2021
Est. completion date December 2024

Study information

Verified date January 2024
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In this study, we are enrolling subjects with moderate to severe acne vulgaris and investigating the use of a commercially available laser in treating acne.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 22
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria: 1. Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol; 2. In good general health, based on answers provided during the screening visit; 3. Subject must be able to read and understand English; 4. Any gender and any Fitzpatrick skin type; 5. Ages 18 through 40; 6. Subjects must have moderate to severe nodular active facial acne vulgaris (PGA 3 or 4) 7. Willing to sun protect treated area for the duration of enrollment in the study and 1 year after treatment; 8. Subjects must be ineligible for or have declined standard of care treatments (e.g. oral isotretinoin therapy). Exclusion Criteria: 1. Participation in another investigational drug or device clinical trial in the past 30 days; 2. Currently undergoing or wish to begin or continue topical treatments; 3. Are pregnant or lactating; 4. History of allergic reaction to topical anesthesia; 5. Subjects may not have undergone oral isotretinoin therapy within the past 12 months; 6. Currently take oral antibiotic or oral therapy for acne; 7. History of keloidal or hypertrophic scarring; 8. Laser treatment in past six months; 9. History of poor wound healing; 10. Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Laser Intervention
Subjects with undergo laser exposure of their active acne vulgaris.

Locations

Country Name City State
United States MGH Clinical Unit for Research Trials & Outcomes in Skin Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Physician's Global Assessment (PGA) of Acne Severity The physician will score the acne vulgaris based on the Physician's Global Assessment (PGA) scale. A score of 0 indicates that residual hyperpigmentation and erythema may be present; a score of 1 indicates that there are a few scattered comedones and a few small papules; a score of 3 indicates that more than half of the face is involved, that there are many comedones, papules, and pustules, and that one nodule may be present; a score of 4 indicates that the entire face is involved, covered with comedones, numerous papules and pustules, and a few nodules and cysts. The change in PGA score will be recorded at each of the 4 study visits, for up to Change in PGA score between baseline visit and post procedural visit
See also
  Status Clinical Trial Phase
Completed NCT04321070 - Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris Phase 1
Recruiting NCT05755256 - The Impact of Probiotics on Skin Hydration in Youth With Mild Acne Phase 2
Completed NCT05131373 - Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris Phase 1
Completed NCT01445301 - Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects Phase 3
Completed NCT03303170 - Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris N/A
Completed NCT04698239 - Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions. N/A
Completed NCT02886715 - A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris Phase 3
Terminated NCT02924428 - Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris N/A
Completed NCT02709902 - Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris Phase 1
Not yet recruiting NCT02525822 - Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris Phase 2
Not yet recruiting NCT02535871 - A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris Phase 3
Not yet recruiting NCT02491060 - A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris Phase 3
Completed NCT02913001 - The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne N/A
Completed NCT02250430 - A Phase 1 Study Assessing Local Cutaneous Effects of SB204 Phase 1
Completed NCT01769664 - A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris Phase 1
Completed NCT01694810 - Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers Phase 1
Completed NCT01727440 - Identifying the Genetic Predictors of Severe Acne Vulgaris and the Outcome of Oral Isotretinoin Treatment N/A
Completed NCT01194375 - A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris Phase 2
Completed NCT00991198 - The Role of Topically Dissolved Oxygen (TDO) to Ameliorate Signs of Photodamage Phase 2
Completed NCT01706250 - U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™ Phase 4