Trial Outcomes & Findings for 755nm Alex Laser for Treatment of Stretch Marks (NCT NCT01745211)
NCT ID: NCT01745211
Last Updated: 2021-02-09
Results Overview
The physician will judge the overall improvement by selecting from improvement ranges of 0-25%, 25-50%, 50-75%, or 75-100% clearance when compared to the baseline.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Follow Up Between 1 and 3 Months Post Last Treatment
Results posted on
2021-02-09
Participant Flow
Each patient's striation area was treated with the array handpiece. No patients were treated with the standard handpiece.
Unit of analysis: striae area
Participant milestones
| Measure |
755nm Alexandrite Laser
755nm Alexandrite laser with array handpiece
|
|---|---|
|
Overall Study
STARTED
|
45 104
|
|
Overall Study
COMPLETED
|
27 64
|
|
Overall Study
NOT COMPLETED
|
18 40
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
755nm Alex Laser for Treatment of Stretch Marks
Baseline characteristics by cohort
| Measure |
755nm Alexandrite Laser
n=45 Participants
755nm Alexandrite laser (standard handpiece)
755nm Alexandrite Laser: 755nm Alexandrite laser with modified and standard handpiece
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · African American
|
6 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
5 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Hispanic
|
9 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · W. Indian
|
1 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Caucasian
|
24 Participants
n=99 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Score I
|
4 Participants
n=99 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Score II
|
9 Participants
n=99 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Score III
|
17 Participants
n=99 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Score IV
|
9 Participants
n=99 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Score V
|
2 Participants
n=99 Participants
|
|
Fitzpatrick Skin Score
Fitzpatrick Skin Score VI
|
4 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Follow Up Between 1 and 3 Months Post Last TreatmentPopulation: 5 subject withdrew and 13 were lost to follow up.
The physician will judge the overall improvement by selecting from improvement ranges of 0-25%, 25-50%, 50-75%, or 75-100% clearance when compared to the baseline.
Outcome measures
| Measure |
755nm Alexandrite Laser With Array Handpiece
n=64 areas with striation
755nm Alexandrite Laser: 755nm Alexandrite laser with array handpiece
|
|---|---|
|
Photographic Evaluation of Striae Clearance
0-25% Improvement from Baseline
|
36 areas with striation
|
|
Photographic Evaluation of Striae Clearance
25-50% Improvement from Baseline
|
17 areas with striation
|
|
Photographic Evaluation of Striae Clearance
50-75% Improvement from Baseline
|
11 areas with striation
|
Adverse Events
755nm Alexandrite Laser
Serious events: 0 serious events
Other events: 26 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
755nm Alexandrite Laser
n=45 participants at risk
755nm Alexandrite laser 755nm Alexandrite Laser: 755nm Alexandrite laser with array handpiece
|
|---|---|
|
Skin and subcutaneous tissue disorders
Redness
|
51.1%
23/45 • Adverse events, whether serious or non-serious, were followed throughout study completion, about 18 months.
|
|
Skin and subcutaneous tissue disorders
Crusting
|
2.2%
1/45 • Adverse events, whether serious or non-serious, were followed throughout study completion, about 18 months.
|
|
Skin and subcutaneous tissue disorders
Blistering
|
2.2%
1/45 • Adverse events, whether serious or non-serious, were followed throughout study completion, about 18 months.
|
|
Skin and subcutaneous tissue disorders
Burn
|
2.2%
1/45 • Adverse events, whether serious or non-serious, were followed throughout study completion, about 18 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
- Publication restrictions are in place
Restriction type: OTHER