PhotoagingPhase 4NCT05471947
TCA 15% Chemical Peel for Improvement in Hand Lentigines
A Phase 4 study testing 15% Trichloroacetic acid + 3% glycolic acid in people with Photoaging and Lentigo, run by Main Line Center for Laser Surgery at 1 site in United States.
Trial summary
This study will evaluate the efficacy of the a 15% trichloroacetic acid + 3% glycolic acid peel combination for treatment of lentigines on the hands. This peel combination is sold over the counter. Patients will receive 3 treatments (spaced 4 weeks). Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Photoaging, Lentigo
- What is being tested?
- 15% Trichloroacetic acid + 3% glycolic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 1 Dec 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age >21
- No laser, chemical peel, neuromodulator, filler treatment to the hands in >3 months
- At least 5 lentigines on each hand
Who cannot join
- Pregnancy
- Breastfeeding
- Allergy to trichloroacetic acid
- Allergy to glycolic acid
- Open wounds on treatment area (hands)
- Active inflammatory disease on treatment area such as atopic dermatitis, psoriasis, dermatomyositis
Trial locations and contacts
1 site in 1 country.
United States1 site
Main Line Center for Laser Surgery
Ardmore, Pennsylvania, 19003
About this study
Official title: Use of TCA 15% + 3% Glycolic Acid Chemical Peel for Improvement in Hand Lentigines
This study will evaluate the efficacy of the a 15% trichloroacetic acid + 3% glycolic acid peel combination for treatment of lentigines on the hands. This peel combination is sold over the counter. Patients will receive 3 treatments (spaced 4 weeks).
Read the detailed description
This clinical investigation is a prospective study consisting of a screening visit, 3 treatment visits, and 1 follow-up visit. Baseline and post-treatment photos will be graded and compared.
A total of 20 patients will be recruited. Following informed consent and screening, subjects' dorsal hands will be photographed.
Patients will receive 3 treatments with the 15% TCA + 3% glycolic acid peel every 4-6 weeks on the dorsal hands. Post-treatment, patients will be instructed to apply Aquaphor to the treated area twice daily for 5 days. Patients' hands will be photographed at each visit.
Four to six weeks after their final treatment, subjects will return for photography.
- Conditions
- Photoaging, Lentigo
- Being tested
- 15% Trichloroacetic acid + 3% glycolic acid
- Keywords
- Photoaging, Chemical Peel, Lentigines, Hand Rejuvenation
- Medical subject headings
- Lentigo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15% Trichloroacetic acid + 3% glycolic acidDrug
Also called 15% TCA + 3% GA
Treatment of the hand with an over-the-counter chemical peel containing 15% trichloroacetic acid + 3% glycolic acid
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment of hand lentigines with 15% trichloroacetic acid + 3% glycolic acid Receives: Drug: 15% Trichloroacetic acid + 3% glycolic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in hand lentigines on a 5-point scale
Photos will be graded on a 5 point scale (0=no change, 1=1-25% change, 2=26-50% change, 3=51-75% change, 4=76-100% change)
Measured: 4-6 weeks after last treatment
Secondary outcomes (1)
Improvement in hand lentigines using the Global Aesthetic Improvement Scale
The GAIS is a validated scale assessing overall change after aesthetic procedures
Measured: 4-6 weeks after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start15 Mar 2023
- Primary completion30 Dec 2023
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for PhotoagingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Main Line Center for Laser Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kachiu Lee, MD, Main Line Center for Laser Surgery
- Investigators
- Kachiu Lee, MD, Principal investigator, Main Line Center for Laser Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471947
- Sponsor's protocol ID
- SC20220721
- Status last verified
- Mar 2025
- First submitted
- 21 Jul 2022
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cook KK, Cook WR Jr. Chemical peel of nonfacial skin using glycolic acid gel augmented with TCA and neutralized based on visual staging. Dermatol Surg. 2000 Nov;26(11):994-9. doi: 10.1046/j.1524-4725.2000.026011994.x.
PubMed 11096382Abd Elazim NE, Makboul R, Botros SN, Awad SM. Cryopeeling versus trichloroacetic acid peeling in the treatment of solar lentigines: Effect on epidermal Langerhans cells. Dermatol Ther. 2020 May;33(3):e13288. doi: 10.1111/dth.13288. Epub 2020 Mar 9.
PubMed 32118343Raziee M, Balighi K, Shabanzadeh-Dehkordi H, Robati RM. Efficacy and safety of cryotherapy vs. trichloroacetic acid in the treatment of solar lentigo. J Eur Acad Dermatol Venereol. 2008 Mar;22(3):316-9. doi: 10.1111/j.1468-3083.2007.02409.x. Epub 2007 Oct 18.
PubMed 18021205Alajmi A, Niaz G, Chen C, Lee K. A 15% Trichloroacetic Acid + 3% Glycolic Acid Chemical Peel Series Improves Appearance of Hand Lentigines: An Evaluator-Blinded, Split-Hand Prospective Trial. Dermatol Surg. 2024 May 1;50(5):467-470. doi: 10.1097/DSS.0000000000004114. Epub 2024 Mar 8.
PubMed 38460193
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of TCA 15% + 3% Glycolic Acid Chemical Peel for Improvement in Hand Lentigines
- ClinicalTrials.gov ID
- NCT05471947
- Acronym / sponsor ID
- SC20220721
- Conditions
- Photoaging, Lentigo
- Keywords
- Photoaging, Chemical Peel, Lentigines, Hand Rejuvenation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Main Line Center for Laser SurgeryUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 25 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy of the a 15% trichloroacetic acid + 3% glycolic acid peel combination for treatment of lentigines on the hands. This peel combination is sold over the counter. Patients will receive 3 treatments (spaced 4 weeks).
Detailed description
This clinical investigation is a prospective study consisting of a screening visit, 3 treatment visits, and 1 follow-up visit. Baseline and post-treatment photos will be graded and compared.
A total of 20 patients will be recruited. Following informed consent and screening, subjects' dorsal hands will be photographed.
Patients will receive 3 treatments with the 15% TCA + 3% glycolic acid peel every 4-6 weeks on the dorsal hands. Post-treatment, patients will be instructed to apply Aquaphor to the treated area twice daily for 5 days. Patients' hands will be photographed at each visit.
Four to six weeks after their final treatment, subjects will return for photography.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: 15% Trichloroacetic acid + 3% glycolic acidTreatment of hand lentigines with 15% trichloroacetic acid + 3% glycolic acid |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >21
- No laser, chemical peel, neuromodulator, filler treatment to the hands in >3 months
- At least 5 lentigines on each hand
Key exclusion criteria (6 listed)
- Pregnancy
- Breastfeeding
- Allergy to trichloroacetic acid
- Allergy to glycolic acid
- Open wounds on treatment area (hands)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 15% Trichloroacetic acid + 3% glycolic acidAlso: 15% TCA + 3% GATreatment of the hand with an over-the-counter chemical peel containing 15% trichloroacetic acid + 3% glycolic acid | Drug | Treatment |
Primary outcome
Improvement in hand lentigines on a 5-point scale
Time frame: 4-6 weeks after last treatment
Photos will be graded on a 5 point scale (0=no change, 1=1-25% change, 2=26-50% change, 3=51-75% change, 4=76-100% change)
1 secondary outcome
Improvement in hand lentigines using the Global Aesthetic Improvement Scale
Time frame: 4-6 weeks after last treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Results publication: PubMed 11096382Cook KK, Cook WR Jr. Chemical peel of nonfacial skin using glycolic acid gel augmented with TCA and neutralized based on visual staging. Dermatol Surg. 2000 Nov;26(11):994-9. doi: 10.1046/j.1524-4725.2000.026011994.x.
- Results publication: PubMed 32118343Abd Elazim NE, Makboul R, Botros SN, Awad SM. Cryopeeling versus trichloroacetic acid peeling in the treatment of solar lentigines: Effect on epidermal Langerhans cells. Dermatol Ther. 2020 May;33(3):e13288. doi: 10.1111/dth.13288. Epub 2020 Mar 9.
- Results publication: PubMed 18021205Raziee M, Balighi K, Shabanzadeh-Dehkordi H, Robati RM. Efficacy and safety of cryotherapy vs. trichloroacetic acid in the treatment of solar lentigo. J Eur Acad Dermatol Venereol. 2008 Mar;22(3):316-9. doi: 10.1111/j.1468-3083.2007.02409.x. Epub 2007 Oct 18.
- Derived from this study: PubMed 38460193Alajmi A, Niaz G, Chen C, Lee K. A 15% Trichloroacetic Acid + 3% Glycolic Acid Chemical Peel Series Improves Appearance of Hand Lentigines: An Evaluator-Blinded, Split-Hand Prospective Trial. Dermatol Surg. 2024 May 1;50(5):467-470. doi: 10.1097/DSS.0000000000004114. Epub 2024 Mar 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kachiu Lee, MD principal investigator
Main Line Center for Laser Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 15% Trichloroacetic acid + 3% glycolic acid in people with Photoaging and Lentigo, run by Main Line Center for Laser Surgery at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in hand lentigines on a 5-point scale (time frame: 4-6 weeks after last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05471947, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2025.