Trial · NCT01778179
A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy
NCT01778179, Not applicable, Completed, Hexsel Dermatology Clinic; results first posted 2020-09-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy. Trials, record NCT01778179. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01778179
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Fixed Triple Combination Cream for Solar Lentigines Associated to Cryotherapy
- NCT number
- NCT01778179
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 50 participants, actual
- Lead sponsor
- Hexsel Dermatology Clinic
- Conditions
- Solar Lentigines
- Interventions
- Tri-luma, Cryotherapy (CRY-AC3® device)
- First posted
- 2013-01-29
- Last updated
- 2020-10-14
- Results first posted
- 2020-09-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Solar Lentigines Count | up to 13 weeks | Solar lentigines count up to 13 weeks |
| Secondary | Change From Baseline in Melanin Levels | Baseline and up to 13 weeks | This assessment was made using a narrowband reflectance spectrophotometer (Mexameter MX18®, Courage-Khazaka, Germany). The measurement is based on absorption/reflection. The probe of the Mexameter® MX 18 emits three specific light wavelengths. A receiver measures the light reflected by the skin. As the quantity of emitted light is defined, the quantity of light absorbed by the skin can be calculated. The melanin is measured by two specific wavelengths (red: 660 nm and near infrared: 880 nm) chosen to correspond to different absorption rates by the pigments. The quantification of melanin is presented as a value that varies from 0-999. The higher the value, the larger is the amount of melanin on the skin. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Solar Lentigines Count | up to 13 weeks | Number of solar lentigines | MEAN | |
| SECONDARY | Change From Baseline in Melanin Levels | Baseline and up to 13 weeks | Arbitrary units | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Solar Lentigines Count | Group 1 | Baseline | 25.7 | Standard Deviation 7.0 | Number of solar lentigines |
| Solar Lentigines Count | Group 2 | Baseline | 26.0 | Standard Deviation 11.0 | Number of solar lentigines |
| Solar Lentigines Count | Group 1 | Week 13 | 8.0 | Standard Deviation 6.0 | Number of solar lentigines |
| Solar Lentigines Count | Group 2 | Week 13 | 11.0 | Standard Deviation 6.0 | Number of solar lentigines |
| Change From Baseline in Melanin Levels | Group 1 | Baseline | 297 | Standard Deviation 69 | Arbitrary units |
| Change From Baseline in Melanin Levels | Group 2 | Baseline | 279 | Standard Deviation 68 | Arbitrary units |
| Change From Baseline in Melanin Levels | Group 1 | Change at Week 13 | -95 | Standard Deviation 59 | Arbitrary units |
| Change From Baseline in Melanin Levels | Group 2 | Change at Week 13 | -41 | Standard Deviation 65 | Arbitrary units |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1 | 25 | |
| Overall Study | STARTED | Group 2 | 25 | |
| Overall Study | COMPLETED | Group 1 | 23 | |
| Overall Study | COMPLETED | Group 2 | 22 | |
| Overall Study | NOT COMPLETED | Group 1 | 2 | |
| Overall Study | NOT COMPLETED | Group 2 | 3 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Erythema | Skin and subcutaneous tissue disorders | Group 1 | 3 | 25 | |
| other | Erythema | Skin and subcutaneous tissue disorders | Group 2 | 2 | 25 | |
| other | Residual blisters from cryotherapy | Skin and subcutaneous tissue disorders | Group 1 | 1 | 25 | |
| other | Residual blisters from cryotherapy | Skin and subcutaneous tissue disorders | Group 2 | 1 | 25 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1 | 0 | 25 |
| Total, all-cause mortality | Group 2 | 0 | 25 |
| Total, other adverse events | Group 1 | 3 | 25 |
| Total, other adverse events | Group 2 | 2 | 25 |
| Total, serious adverse events | Group 1 | 0 | 25 |
| Total, serious adverse events | Group 2 | 0 | 25 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1 vs Group 2: deaths from any cause | Trial comparisons |
| Group 1 vs Group 2: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01778179
GET https://conductscience.org/api/trials/v1/NCT01778179/registered